Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 07, 2019 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | Savara Inc. | |
Entity Central Index Key | 0001160308 | |
Entity Interactive Data Current | Yes | |
Trading Symbol | SVRA | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 41,210,386 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-32157 | |
Entity Tax Identification Number | 84-1318182 | |
Entity Address, Address Line One | 6836 Bee Cave Road | |
Entity Address, Address Line Two | Building III | |
Entity Address, Address Line Three | Suite 200 | |
Entity Address, City or Town | Austin | |
Entity Address, State or Province | TX | |
Entity Address, Postal Zip Code | 78746 | |
City Area Code | 512 | |
Local Phone Number | 614-1848 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 17,785 | $ 24,301 |
Short-term investments | 88,496 | 86,529 |
Prepaid expenses and other current assets | 2,065 | 2,514 |
Total current assets | 108,346 | 113,344 |
Property and equipment, net | 393 | 522 |
In-process R&D | 10,806 | 11,372 |
Goodwill | 19,432 | 26,918 |
Other non-current assets | 1,651 | 131 |
Total assets | 140,628 | 152,287 |
Current liabilities: | ||
Accounts payable | 2,903 | 3,879 |
Accrued expenses and other current liabilities | 5,388 | 3,375 |
Total current liabilities | 8,291 | 7,254 |
Long-term liabilities: | ||
Debt facility | 24,962 | 24,530 |
Contingent consideration | 12,214 | |
Other long-term liabilities | 572 | 70 |
Total liabilities | 33,825 | 44,068 |
Stockholders’ equity: | ||
Common stock, $0.001 par value, 200,000,000 shares authorized as of September 30, 2019 and December 31, 2018; 41,208,261 and 35,146,096 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively | 42 | 36 |
Additional paid-in capital | 283,170 | 237,702 |
Accumulated other comprehensive income (loss) | (236) | 200 |
Accumulated deficit | (176,173) | (129,719) |
Total stockholders’ equity | 106,803 | 108,219 |
Total liabilities and stockholders’ equity | $ 140,628 | $ 152,287 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 41,208,261 | 35,146,096 |
Common stock, shares outstanding | 41,208,261 | 35,146,096 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Operating expenses: | ||||
Research and development | $ 9,575 | $ 9,509 | $ 30,058 | $ 27,316 |
General and administrative | 2,811 | 3,148 | 9,785 | 7,402 |
Impairment of acquired IPR&D | 21,692 | |||
Impairment of goodwill | 7,420 | |||
Depreciation and amortization | 56 | 127 | 253 | 387 |
Total operating expenses | 12,442 | 12,784 | 47,516 | 56,797 |
Loss from operations | (12,442) | (12,784) | (47,516) | (56,797) |
Other income, net: | ||||
Interest income (expense), net | 5 | 111 | 16 | (106) |
Foreign currency exchange gain (loss) | 116 | (7) | 167 | 87 |
Tax credit income | 54 | 110 | 1,133 | 1,311 |
Change in fair value of financial instruments | (136) | 10 | (254) | (52) |
Total other income | 39 | 224 | 1,062 | 1,240 |
Loss before income taxes | (12,403) | (12,560) | (46,454) | (55,557) |
Income tax benefit | 4,555 | |||
Net loss | $ (12,403) | $ (12,560) | $ (46,454) | $ (51,002) |
Net loss per share: | ||||
Basic and diluted | $ (0.30) | $ (0.36) | $ (1.20) | $ (1.57) |
Weighted average common shares outstanding: | ||||
Basic and diluted | 41,727,259 | 34,483,563 | 38,749,002 | 32,423,510 |
Other comprehensive loss: | ||||
Loss on foreign currency translation | $ (436) | $ (105) | $ (570) | $ (620) |
Unrealized gain (loss) on short-term investments | (12) | 13 | 134 | 26 |
Total comprehensive loss | $ (12,851) | $ (12,652) | $ (46,890) | $ (51,596) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] |
Beginning balances at Dec. 31, 2017 | $ 119,309 | $ 32 | $ 186,522 | $ 958 | $ (68,203) |
Beginning balance, shares at Dec. 31, 2017 | 30,509,522 | ||||
Issuance of common stock upon at the market offerings, net | 493 | 493 | |||
Issuance of common stock upon at The market offering, net, shares | 46,900 | ||||
Issuance of common stock for settlement of RSUs, shares | 11,250 | ||||
Net Issuance of common stock upon cashless exercise of stock options, shares | 28,655 | ||||
Issuance of common stock upon exercise of stock options | 3 | 3 | |||
Issuance of common stock upon exercise of stock options, shares | 6,000 | ||||
Issuance of common stock upon exercise of warrants | 18 | 18 | |||
Issuance of common stock upon exercise of warrants, Shares | 2,039 | ||||
Stock-based compensation | 412 | 412 | |||
Foreign exchange translation adjustment | 341 | 341 | |||
Unrealized gain (loss) on short-term investments | (24) | (24) | |||
Net loss incurred | (26,848) | (26,848) | |||
Ending balance at Mar. 31, 2018 | 93,704 | $ 32 | 187,448 | 1,275 | (95,051) |
Ending balance, shares at Mar. 31, 2018 | 30,604,366 | ||||
Beginning balances at Dec. 31, 2017 | 119,309 | $ 32 | 186,522 | 958 | (68,203) |
Beginning balance, shares at Dec. 31, 2017 | 30,509,522 | ||||
Foreign exchange translation adjustment | (620) | ||||
Unrealized gain (loss) on short-term investments | 26 | ||||
Net loss incurred | (51,002) | ||||
Ending balance at Sep. 30, 2018 | 117,854 | $ 36 | 236,659 | 364 | (119,205) |
Ending balance, shares at Sep. 30, 2018 | 35,120,540 | ||||
Beginning balances at Mar. 31, 2018 | 93,704 | $ 32 | 187,448 | 1,275 | (95,051) |
Beginning balance, shares at Mar. 31, 2018 | 30,604,366 | ||||
Issuance of common stock for settlement of RSUs, shares | 13,125 | ||||
Net Issuance of common stock upon cashless exercise of stock options, shares | 87,099 | ||||
Issuance of common stock upon exercise of stock options | 30 | 30 | |||
Issuance of common stock upon exercise of stock options, shares | 24,521 | ||||
Issuance of common stock upon exercise of warrants | 1 | 1 | |||
Issuance of common stock upon exercise of warrants, Shares | 84 | ||||
Common stock issued for purchase of assets | 995 | 995 | |||
Common stock issued for purchase of assets, shares | 107,579 | ||||
Stock-based compensation | 392 | 392 | |||
Foreign exchange translation adjustment | (856) | (856) | |||
Unrealized gain (loss) on short-term investments | 37 | 37 | |||
Net loss incurred | (11,594) | (11,594) | |||
Ending balance at Jun. 30, 2018 | 82,709 | $ 32 | 188,866 | 456 | (106,645) |
Ending balance, shares at Jun. 30, 2018 | 30,836,774 | ||||
Issuance of common stock upon public offering, net | 45,792 | $ 4 | 45,788 | ||
Issuance of common stock upon public offering, net, shares | 4,250,000 | ||||
Issuance of common stock for settlement of RSUs, shares | 13,125 | ||||
Issuance of common stock upon cashless exercise of stock options | 17 | 17 | |||
Net Issuance of common stock upon cashless exercise of stock options, shares | 20,641 | ||||
Stock-based compensation | 1,988 | 1,988 | |||
Foreign exchange translation adjustment | (105) | (105) | |||
Unrealized gain (loss) on short-term investments | 13 | 13 | |||
Net loss incurred | (12,560) | (12,560) | |||
Ending balance at Sep. 30, 2018 | 117,854 | $ 36 | 236,659 | 364 | (119,205) |
Ending balance, shares at Sep. 30, 2018 | 35,120,540 | ||||
Beginning balances at Dec. 31, 2018 | 108,219 | $ 36 | 237,702 | 200 | (129,719) |
Beginning balance, shares at Dec. 31, 2018 | 35,146,096 | ||||
Issuance of common stock upon at the market offerings, net | 4,890 | 4,890 | |||
Issuance of common stock upon at The market offering, net, shares | 647,426 | ||||
Issuance of common stock for settlement of RSUs, shares | 13,125 | ||||
Issuance of common stock upon exercise of stock options | 6 | 6 | |||
Issuance of common stock upon exercise of stock options, shares | 23,593 | ||||
Stock-based compensation | 1,000 | 1,000 | |||
Foreign exchange translation adjustment | (225) | (225) | |||
Unrealized gain (loss) on short-term investments | 26 | 26 | |||
Net loss incurred | (12,112) | (12,112) | |||
Ending balance at Mar. 31, 2019 | 101,804 | $ 36 | 243,598 | 1 | (141,831) |
Ending balance, shares at Mar. 31, 2019 | 35,830,240 | ||||
Beginning balances at Dec. 31, 2018 | 108,219 | $ 36 | 237,702 | 200 | (129,719) |
Beginning balance, shares at Dec. 31, 2018 | 35,146,096 | ||||
Foreign exchange translation adjustment | (570) | ||||
Unrealized gain (loss) on short-term investments | 134 | ||||
Net loss incurred | (46,454) | ||||
Ending balance at Sep. 30, 2019 | 106,803 | $ 42 | 283,170 | (236) | (176,173) |
Ending balance, shares at Sep. 30, 2019 | 41,208,261 | ||||
Beginning balances at Mar. 31, 2019 | 101,804 | $ 36 | 243,598 | 1 | (141,831) |
Beginning balance, shares at Mar. 31, 2019 | 35,830,240 | ||||
Issuance of common stock upon at the market offerings, net | 19,037 | $ 2 | 19,035 | ||
Issuance of common stock upon at The market offering, net, shares | 1,870,500 | ||||
Issuance of common stock upon settlement of contingent liability | 12,478 | $ 1 | 12,477 | ||
Issuance of common stock upon settlement of contingent liability, shares | 1,105,216 | ||||
Issuance of common stock for settlement of RSUs, shares | 13,125 | ||||
Issuance of common stock upon cashless exercise of warrants, shares | 11,119 | ||||
Issuance of common stock upon exercise of stock options | 62 | $ 1 | 61 | ||
Issuance of common stock upon exercise of stock options, shares | 73,630 | ||||
Stock-based compensation | 1,146 | 1,146 | |||
Foreign exchange translation adjustment | 91 | 91 | |||
Unrealized gain (loss) on short-term investments | 120 | 120 | |||
Net loss incurred | (21,939) | (21,939) | |||
Ending balance at Jun. 30, 2019 | 112,799 | $ 40 | 276,317 | 212 | (163,770) |
Ending balance, shares at Jun. 30, 2019 | 38,903,830 | ||||
Issuance of common stock upon at the market offerings, net | 5,664 | $ 2 | 5,662 | ||
Issuance of common stock upon at The market offering, net, shares | 2,251,800 | ||||
Issuance of common stock for settlement of RSUs, shares | 13,125 | ||||
Net Issuance of common stock upon cashless exercise of stock options, shares | 39,506 | ||||
Issuance of common stock upon exercise of stock options | 45 | 45 | |||
Stock-based compensation | 1,146 | 1,146 | |||
Foreign exchange translation adjustment | (436) | (436) | |||
Unrealized gain (loss) on short-term investments | (12) | (12) | |||
Net loss incurred | (12,403) | (12,403) | |||
Ending balance at Sep. 30, 2019 | $ 106,803 | $ 42 | $ 283,170 | $ (236) | $ (176,173) |
Ending balance, shares at Sep. 30, 2019 | 41,208,261 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (46,454) | $ (51,002) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization including right-of-use assets | 772 | 387 |
Impairment of acquired IPR&D | 21,692 | |
Impairment of goodwill | 7,420 | |
Changes in fair value of financial instruments | 254 | 52 |
Change in fair value of contingent consideration | 264 | 131 |
Noncash interest (income) / expense | 42 | 83 |
Acquired IPR&D | 995 | |
Foreign currency loss | (167) | (87) |
Amortization of debt issuance costs | 432 | 332 |
Accretion on discount to short-term investments | (1,004) | (546) |
Stock-based compensation | 3,292 | 2,792 |
Benefit for deferred taxes | (4,555) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 394 | (424) |
Non-current assets | (672) | |
Accounts payable and accrued expenses and other current liabilities | 429 | 1,391 |
Long-term liabilities | (179) | (23) |
Net cash used in operating activities | (35,177) | (28,782) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (138) | (81) |
Purchase of available-for-sale securities, net | (104,204) | (88,104) |
Maturities of available-for-sale securities | 89,200 | 64,346 |
Sale of available-for-sale securities, net | 14,131 | 9,351 |
Net cash used by investing activities | (1,011) | (14,488) |
Cash flows from financing activities: | ||
Issuance of common stock upon exercise of warrants | 19 | |
Issuance of common stock upon public offerings, net | 45,792 | |
Issuance of common stock upon at the market offerings, net | 29,591 | 493 |
Proceeds from exercise of stock options | 111 | 50 |
Capital lease obligation principal payments | (42) | (257) |
Net cash provided by financing activities | 29,660 | 46,097 |
Effect of exchange rate changes on cash and cash equivalents | 12 | (2) |
Increase (decrease) in cash and cash equivalents | (6,516) | 2,825 |
Cash and cash equivalents beginning of period | 24,301 | 22,121 |
Cash and cash equivalents end of period | 17,785 | 24,946 |
Noncash transaction: | ||
Common stock issued for IPR&D, net | 995 | |
Settlement of contingent consideration | 12,478 | |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | $ 1,596 | $ 1,038 |
Description of Business and Bas
Description of Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Description of Business and Basis of Presentation | 1. Description of Business and Basis of Presentation Description of Business Savara Inc. (together with its subsidiaries. “Savara,” the “Company,” “we” or “us”) is an orphan lung disease company. The Company’s pipeline comprises of Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (“GM-CSF”), in Phase 3 development Since inception, Savara has devoted substantially all of its efforts and resources to identifying and developing its product candidates, recruiting personnel, and raising capital. Savara has incurred operating losses and negative cash flow from operations and has no product revenue from inception to date. The Company has not yet commenced commercial operations. Basis of Presentation The interim condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) as defined by the Financial Accounting Standards Board (“FASB”). These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2018. Certain prior period amounts have been reclassified for consistency with current period presentation. Unaudited Interim Financial Information The interim condensed consolidated financial statements included in this document are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for a fair statement of the Company’s financial position as of September 30, 2019, and its results of operations for the three and nine months ended September 30, 2019 and 2018, and cash flows for the nine months ended September 30, 2019 and 2018. The results of operations for interim periods shown in this report are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other future annual or interim period. The December 31, 2018 consolidated balance sheet was derived from audited financial statements but does not include all disclosures required by U.S. GAAP. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2018. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Liquidity As of September 30, 2019, the Company had an accumulated deficit of approximately $176.2 million. The Company also had negative cash flow from operations of approximately $35.2 million during the nine months ended September 30, 2019. The cost to further develop and obtain regulatory approval for any drug is substantial and, as noted below, the Company may have to take certain steps to maintain a positive cash position. Accordingly, the Company will need additional capital to further fund the development of, and seek regulatory approvals for, its product candidates and begin to commercialize any approved products. Currently, the Company is primarily focused on the development of respiratory drugs and believes such activities will result in the Company’s continued incurrence of significant research and development and other expenses related to those programs. If the clinical trials for any of the Company’s product candidates fail or produce unsuccessful results and those product candidates do not gain regulatory approval, or if any of the Company’s product candidates, if approved, fail to achieve market acceptance, the Company may never become profitable. Even if the Company achieves profitability in the future, it may not be able to sustain profitability in subsequent periods. The Company intends to cover its future operating expenses through cash and cash equivalents on hand and through a combination of equity offerings, debt financings, government or other third-party funding, and other collaborations and strategic alliances. The Company cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its stockholders. While the Company had cash and cash equivalents of $17.8 million and short-term investments of $88.5 million as of September 30, 2019, the Company intends to continue to raise additional capital as needed through the issuance of additional equity securities and potentially through borrowings, and strategic alliances with partner companies. However, if such financings are not available timely and at adequate levels, the Company will need to reevaluate its operating plans. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Principles of Consolidation The interim condensed consolidated financial statements of the Company are stated in U.S. dollars and are prepared using U.S. GAAP. These financial statements include the accounts of the Company and its wholly owned subsidiaries. The financial statements of the Company’s wholly owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in “Accumulated other comprehensive income (loss).” All intercompany transactions and accounts have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Management’s estimates include those related to the accrual of research and development and general and administrative costs, certain financial instruments recorded at fair value, stock-based compensation, and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that it believes to be reasonable under the circumstances. Accordingly, actual results could be materially different from those estimates. Risks and Uncertainties The product candidates being developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or foreign regulatory agencies prior to commercial sales. There can be no assurance that the Company’s product candidates will receive the necessary approvals. If the Company is denied regulatory approval of its product candidates, or if approval is delayed, it may have a material adverse impact on the Company’s business, results of operations, and its financial position. The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the successful discovery and development of drug candidates, raising additional capital, development of competing drugs and therapies, protection of proprietary technology, and market acceptance of the Company’s products. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success. Cash and Cash Equivalents Cash and cash equivalents consist of cash and institutional bank money market accounts with original maturities of three months or less when acquired and are stated at cost, which approximates fair value. Short-term Investments The Company has classified its investments in debt securities with readily determinable fair value as available-for-sale securities. These securities are carried at estimated fair value with the aggregate unrealized gains and losses related to these investments reflected as a part of “Accumulated other comprehensive income The fair value of the investments is based on the specific quoted market price of the securities or comparable securities at the balance sheet dates. Investments in debt securities are considered to be impaired when a decline in fair value is judged to be other than temporary because the Company either intends to sell or it is more-likely-than not that it will have to sell the impaired security before recovery. Once a decline in fair value is determined to be other than temporary, an impairment charge is recorded and a new cost basis in the investment is established. Concentration of Credit Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash and cash equivalents and foreign exchange derivatives not designated as hedging. The Company places its cash and cash equivalents with a limited number of high-quality financial institutions and at times may exceed the amount of insurance provided on such deposits. Accrued Research and Development Costs The Company records the costs associated with research, nonclinical studies, clinical trials, and manufacturing development as incurred. These costs are a significant component of the Company’s research and development expenses, with a substantial portion of the Company’s on-going research and development activities conducted by third-party service providers, including contract research and manufacturing organizations. The Company accrues for expenses resulting from obligations under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other outside service providers for which payment flows do not match the periods over which materials or services are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs, and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. The Company makes significant judgments and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO, or outside service provider, the payments will be recorded as a prepaid asset which will be amortized or expensed as the contracted services are performed. As actual costs become known, the Company adjusts its prepaids and accruals. Inputs, such as the services performed, the number of patients enrolled, or the study duration, may vary from the Company’s estimates resulting in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. To date, the Company has not experienced any material deviations between accrued and actual research and development expenses. Business Combinations Assets acquired and liabilities assumed as part of a business acquisition are recorded at their estimated fair value at the date of acquisition. The excess of purchase price over the fair value of assets acquired and liabilities assumed is recorded as goodwill. Determining fair value of identifiable assets, particularly intangibles, and liabilities acquired also requires management to make estimates, which are based on available information and, in some cases, assumptions with respect to the timing and amount of future revenue and expenses associated with an asset. Goodwill, Acquired In-Process Research and Development, and Deferred Tax Liability Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill is not amortized, but assessed for impairment on an annual basis or more frequently if impairment indicators exist. Current guidance issued by the FASB, as previously adopted by the Company, provides an impairment model whereby the Company has the option to implement a one-step method for determining impairment of goodwill, simplifying the subsequent measurement of goodwill by eliminating Step 2 (quantitative calculation of measuring a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill) from the goodwill impairment test. Under the amendments in this guidance, an entity should perform its annual goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, an entity should consider income tax effects from any tax-deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss, if applicable. Acquired in-process research and development (“IPR&D”) is considered an indefinite-lived intangible asset and is assessed for impairment annually or more frequently if impairment indicators exist. The Company adopted accounting guidance related to its annual acquired IPR&D impairment test, a two-step method, which allows the Company to first assess qualitative factors before performing a quantitative assessment of the fair value of a reporting unit. If it is determined on the basis of qualitative factors that the fair value of the IPR&D is more likely than not less than the carrying amount, a quantitative impairment test is required. If the associated research and development effort is abandoned, the related asset will be written-off, and the Company will record a noncash impairment loss on its consolidated statements of operations and comprehensive loss. For those products that reach commercialization, the IPR&D asset will be amortized over its estimated useful life. The Company performs its annual goodwill impairment test and IPR&D impairment test, as described above, as of June 30th and September 30th, respectively, or whenever an event or change in circumstances occurs that would require reassessment of the recoverability of those assets. For the nine months ended September 30, 2019, the Company experienced no change in the carrying value of goodwill and a decrease of approximately $0.6 million in the carrying value of IPR&D, which was due to foreign currency translation. Due to the Company’s current carrying value, if we experience material declines in our stock price, goodwill impairment may occur. For instance, the Company determined that a triggering event had occurred during the fourth quarter of 2019 under which the Company’s stock price experienced a significant decline requiring the impairment testing of its goodwill which will result in an impairment charge of $19.4 million in the fourth quarter of 2019 reducing the Company’s carrying value of its goodwill to its fair value, which was determined to be zero (See Note 14). Similarly, the Company completed the aforementioned qualitative and quantitative impairment testing of its IPR&D following this fourth quarter 2019 triggering event and concluded that there was no impairment to its IPR&D. Tax Credit Receivable The Company has recorded a Danish tax credit earned by its subsidiary, Savara ApS, as of September 30, 2019. Under Danish tax law, Denmark remits a research and development tax credit equal to 22% of qualified research and development expenditures, not to exceed established thresholds. As of September 30, 2019, credits totaling $1.6 million had been generated but not yet received. Of this total Danish tax credit, $0.8 million is related to research and development activities incurred during the year ended December 31, 2018 and is recorded in “Prepaid expenses and other current assets” and expected to be received in the fourth quarter of 2019. The remaining portion of the Danish tax credit of $0.8 million, which was generated during the nine months ended September 30, 2019, is recorded in “Other non-current assets” and is expected to be received in the fourth quarter of 2020. The Company also recognized tax credit income for the nine months ended September 30, 2019 as provided by the Australian Taxation Office for qualified research and development expenditures incurred through our subsidiary, Savara Australia Pty. Limited. Under Australian tax law, Australia remits a research and development tax credit equal to 43.5% of qualified research and development expenditures, not to exceed established thresholds. As of September 30, 2019, credits totaling $0.3 million had been generated but not yet received and such amount is recorded in “Prepaid expenses and other current assets” with expectation of receipt in the first half of the year ending December 31, 2020. Leases In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases (Topic 842)” (“ASU 2016-02”) as codified in Accounting Standards Codification (“ASC”) No. 842 (“ASC 842”). ASU 2016-02, ASC 842, and additional issued guidance are intended to improve financial reporting of leasing transactions by requiring organizations that lease assets to recognize assets and liabilities for the rights and obligations created by leases that extend more than twelve months. This accounting update also requires additional disclosures surrounding the amount, timing, and uncertainty of cash flows arising from leases. ASU 2016-02 is effective for financial statements issued for annual and interim periods beginning after December 15, 2018 for public business entities. The Company adopted ASU 2016-02 as of January 1, 2019 using the effective date transition method of implementation offered under ASU 2018-11, “Leases (Topic 842) – Targeted Improvements” issued in July 2018 (“ASU 2018-11”), under which entities may change their date of initial application of ASU 2016-02 to the beginning of the period of adoption, or January 1, 2019, in the case of Savara. Accordingly, the Company is required to apply the prior lease guidance pursuant to ASC Topic 840 in the comparative periods, provide the disclosures required by ASC Topic 840 for all periods that continue to be presented in accordance with ASC Topic 840, recognize the effects of applying ASC 842 as a cumulative-effect adjustment to retained earnings as of January 1, 2019, if any, and provide certain disclosures under ASC 842 (see Note 10). The Company has also elected the package of practical expedients, applied by class of underlying asset, permitted in ASU 2018-11. Accordingly, the Company accounted for its existing operating leases as operating leases under the new guidance, without reassessing (a) whether the contracts contain a lease under ASC 842, (b) whether classification of the operating leases would be different in accordance with ASC 842, and (c) whether the unamortized initial direct costs before transition adjustments (as of the period of adoption) would have met the definition of initial direct costs in ASC 842 at lease commencement, and the Company did not separate lease and non-lease components. As a result of the adoption of the new lease accounting guidance using the effective date transition method, on January 1, 2019, the Company recognized (a) a lease liability of approximately $1.4 million, which represents the present value of the remaining lease payments, as of the date of adoption, of approximately $1.5 million, discounted using the Company’s incremental borrowing rate of 8.5%, and (b) a right-of-use asset of approximately $1.4 million. The adoption of the new standard did not result in any adjustment to the Company’s retained earnings as of January 1, 2019. The adoption of this standard did not have a material impact on the Company’s condensed consolidated balance sheets, cash used/provided from operating, investing, or financing activities in the condensed consolidated statements of cash flows, or on the Company’s operating results. The most significant impact was the recognition of right-of-use assets for operating leases, which are reflected in “Other non-current assets,” and lease liabilities for operating leases, which are reflected in “Accrued expenses and other current liabilities,” for the current portion of the lease liabilities, and in “Other long-term liabilities” for the non-current portion of the lease liabilities, respectively (See Note 10). Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. Our chief operating decision maker is the chief executive officer. We have one operating segment, specialty pharmaceuticals within the respiratory system. Fair Value of Financial Instruments The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability. The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value. The three tiers are defined as follows: • Level 1 – Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets; • Level 2 – Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and • Level 3 – Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions. Financial instruments carried at fair value include cash and cash equivalents, short-term investments, contingent consideration, prior to its settlement and full satisfaction in May 2019, and foreign exchange derivatives not designated as hedging instruments. Financial instruments not carried at fair value include accounts payable and accrued liabilities. The carrying amounts of these financial instruments approximate fair value due to the highly liquid nature of these short-term instruments. Revenue Recognition The Company will record revenue based on a five-step model in accordance with ASC 606, “Revenue from Contracts with Customers.” To date, the Company has not generated any product revenue from its drug candidates. The Company’s ability to generate product revenues, which the Company does not expect will occur in the near term, if ever, will depend heavily on the successful development, regulatory approval, and eventual commercialization of the Company’s product candidates. Milestone Revenue The Company is subject to a license agreement related to its Molgradex product candidate (see Note 12), which includes certain milestone payments to be remunerated by the licensee to Savara. Pursuant to the license agreement, the Company identifies the performance obligations, determines the transaction price, allocates the contract transaction price to the performance obligations, and recognizes the revenue when (or as) the performance obligation is satisfied. The Company identifies the performance obligations included within the license agreement and evaluates which performance obligations are distinct. The milestone payments are a form of variable consideration as the payments are contingent upon achievement of a substantive event. The milestone payments are estimated and included in the transaction price when the Company determines, under the variable consideration constraint, that it is probable that there will not be a significant reversal of cumulative revenue recognized in future periods. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the estimate of the overall transaction price. Net Loss per Share Basic net loss attributable to common stockholders per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock and pre-funded warrants outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive. Stock-Based Compensation The Company recognizes the cost of stock-based awards granted to employees based on the estimated grant-date fair value of the awards. The value of the portion of the award that is ultimately expected to vest is recognized as expense ratably over the requisite service period. The Company recognizes the compensation costs for awards that vest over several years on a straight-line basis over the vesting period (see Note 11). Forfeitures are recognized when they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures arise. Manufacturing and Other Commitments and Contingencies The Company is subject to various manufacturing royalties and payments related to its product candidate, Molgradex. Under a manufacture and supply agreement with the active pharmaceutical ingredients (“API”) manufacturer, Savara must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below. Additionally, upon first receipt of marketing approval by Savara from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, Savara shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country. Pursuant to a license agreement (see Note 12) between the Company and a Japanese licensee regarding the development and commercialization of Molgradex for the treatment of aPAP in Japan, the Company shall fund the licensee fifty percent (50%), up to a maximum of approximately $0.8 million, of the external costs associated with specific regulatory and filing activities to be conducted by the licensee. As of September 30, 2019, no costs have been incurred. Under an agreement with a medical education and research foundation entered into on October 8, 2018, the Company is subject to a milestone payment for the use of proprietary information and material in intellectual property filings related to the application of Molgradex in the treatment of NTM. The Company will owe royalties to the foundation based on net sales of Molgradex for the treatment of NTM equal to one half of one percent (0.5%) after publication of the intellectual property filings and one quarter of one percent (0.25%) prior to the publication or in the event publication does not occur, with respect to the specified intellectual property filings. The Company is also subject to certain contingent milestone payments, disclosed in the following table, payable to the manufacturer of the nebulizer used to administer Molgradex. The change in the amount of the milestone payments from June 30, 2019 to September 30, 2019 was solely related to changes in foreign currency exchange rates. In addition to these milestones, the Company will owe a royalty to the manufacturer of the nebulizer based on net sales. The royalty rate ranges from three and one half percent (3.5%) to five percent (5%) depending on the device technology used by the Company to administer the product. Manufacturing and Other Contingent Milestone and Co-Development Payments (in thousands): September 30, 2019 Molgradex API manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of Molgradex $ 2,600 Molgradex nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized to administer Molgradex 7,417 Molgradex Japanese licensee: Co-marketing and regulatory costs 750 Medical education and research foundation: First commercial sale in the U.S. of Molgradex in treatment of NTM 500 Total manufacturing and other commitments $ 11,267 The milestones and co-marketing commitments disclosed above reflect the activities that have (i) not been met or incurred; (ii) not been remunerated; and (iii) not accrued, as the activities are not deemed probable or reasonably estimable, as of September 30, 2019. Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of a change in tax rates on deferred tax assets and liabilities will be recognized in the period that includes the enactment date. A valuation allowance is established against the deferred tax assets to reduce their carrying value to an amount that is more likely than not to be realized. Recent Accounting Pronouncements In August 2018, the FASB issued ASU 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurement.” The update eliminates, adds, and modifies certain disclosure requirements for fair value measurements as part of its disclosure framework project. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years, with early adoption permitted. The Company has not adopted ASU 2018-13 and is currently evaluating its impact on our condensed consolidated financial statements. In November 2018, the FASB issued ASU 2018-18, “Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606.” The update clarifies that certain transactions between collaborative partners should be accounted for as revenue under the new revenue standard ASC 606 when the collaborative partner is a customer, specifies the unit of account for determining whether a transaction with a customer is a distinct good or service under ASC 606, and precludes a company from presenting transactions with a collaborative partner that are not in the scope of ASC 606 together with revenue from contracts with customers. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years, with early adoption permitted. The Company has reviewed ASU 2018-18 and concluded that it has no impact on our condensed consolidated financial statements. In March 2019, the FASB issued ASU 2019-01, “Leases (Topic 842): Codification Improvements,” which aims to clarify and revise guidance for certain lessors and clarify interim transition disclosure requirements for ASC 842. ASU 2019-01 is effective for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years, with early adoption permitted. The Company has not yet adopted ASU 2019-01 and is currently evaluating its impact on our condensed consolidated financial statements. In April 2019, the FASB issued ASU 2019-04, “Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments.” The Company has reviewed ASU 2019-01 and concluded that it has no impact on our condensed consolidated financial statements. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2019 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Prepaid Expenses and Other Current Assets | 3. Prepaid expenses and other current assets Prepaid expenses consisted of (in thousands): September 30, 2019 December 31, 2018 R&D tax credit receivable $ 1,140 $ 1,263 Prepaid contracted research and development costs 319 561 VAT receivable 265 421 Prepaid insurance 74 162 Deposits and other 267 107 Total prepaid expenses and other current assets $ 2,065 $ 2,514 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 4. Accrued expenses and other current liabilities Accrued expenses and other current liabilities consisted of (in thousands): September 30, 2019 December 31, 2018 Accrued contracted research and development costs $ 3,210 $ 2,044 Accrued general and administrative costs 301 371 Accrued compensation 1,177 643 Foreign currency exchange derivative 136 26 Deferred revenue — 250 Lease liability 564 — Other — 41 Total accrued expenses and other current liabilities $ 5,388 $ 3,375 |
Short-term Investments
Short-term Investments | 9 Months Ended |
Sep. 30, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Short-term Investments | 5. Short-term Investments The Company’s investment policy seeks to preserve capital and maintain sufficient liquidity to meet operational and other needs of the business. The following table summarizes, by major security type, the Company’s investments (in thousands): As of September 30, 2019: Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 28,475 $ 21 $ — $ 28,496 Asset backed securities 8,791 16 — 8,807 Corporate securities 31,745 66 — 31,811 Commercial paper 19,382 — — 19,382 Total short-term investments $ 88,393 $ 103 $ — $ 88,496 As of December 31, 2018: Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 15,967 $ — $ (2 ) $ 15,965 Asset backed securities 8,595 — (7 ) 8,588 Corporate securities 19,975 — (21 ) 19,954 Commercial paper 42,022 — — 42,022 Total short-term investments $ 86,559 $ — $ (30 ) $ 86,529 The Company has classified its investments as available-for-sale securities. These securities are carried at estimated fair value with the aggregate unrealized gains and losses related to these investments reflected as a part of “Accumulated other comprehensive income (loss)” in the condensed consolidated balance sheets. Classification as short-term or long-term is based upon whether the maturity of the debt securities is less than or greater than twelve months. There were no significant realized gains or losses related to investments for the nine months ended September 30, 2019 and September 30, 2018. |
Debt Facility
Debt Facility | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Debt Facility | 6. Debt Facility On April 28, 2017, the Company entered into a loan and security agreement with Silicon Valley Bank, as amended on October 31, 2017 (the “Loan Agreement”), which provided for a $15.0 million credit facility that was made available in two equal tranches. In December 2018, the Company entered into an amendment to the Loan Agreement (the “Loan Amendment”) to increase the amount of the term loan facility from $15.0 million to $45.0 million and make certain other changes. The Loan Agreement, as amended, provides that the funds are available in two tranches: (i) $25.0 million became available upon the effectiveness of the Loan Amendment, of which $15.0 million was used to refinance the existing amount outstanding under the loan facility, and (ii) $20.0 million which expired on September 30, 2019. Silicon Valley Bank has been granted a perfected first priority lien in all of our assets with a negative pledge on our intellectual property. The Loan Agreement, as amended, contains customary affirmative and negative covenants, including among others, covenants limiting our ability and our subsidiaries’ ability to dispose of assets, permit a change in control, merge or consolidate, make acquisitions, incur indebtedness, grant liens, make investments, make certain restricted payments and enter into transactions with affiliates, in each case subject to certain exceptions. Following the Loan Amendment, the loans bear interest at the prime rate reported in The Wall Street Journal, plus a spread of 3.0%. Interest only payments are due through October 2020 followed by monthly payments of principal plus interest over the following twenty-five (25) months and a maturity date of November 1, 2022. The Loan Agreement, as amended, includes The end of term charge equal to 6.0% of the amount of principal borrowed will be due on the scheduled maturity date and is being recognized as an increase to the principal with a corresponding charge to interest expense over the term of the facility using the effective interest method. Upon the funding of each tranche, as described above, under the Loan Agreement, the Company was obligated to issue warrants to purchase shares of its common stock, as described below. Upon funding the first tranche of the Loan Agreement, the Company issued warrants to purchase 24,725 shares of the Company’s common stock at an exercise price of $9.10 per share, with a ten-year life, expiring April 28, 2027 (“April 2017 Warrants”). Upon funding the second tranche of the Loan Agreement, the Company issued warrants to purchase 41,736 shares of the Company’s common stock at an exercise price of $5.39 per share with a ten-year life, expiring June 15, 2027 (“June 2017 Warrants”). The April 2017 Warrants and June 2017 Warrants were valued using the Black-Scholes option pricing model with the following assumptions: volatility of 71.42% and 71.57%, respectively, expected term of ten years, risk-free interest rate of 2.33% and 2.16%, respectively, and a zero-dividend yield. The collective warrant fair value of $0.4 million has been recorded as a debt discount and is being amortized through interest expense using the effective interest method through the scheduled maturity date. Upon the funding of the tranche in connection with the Loan Amendment, the Company was obligated to issue warrants to purchase 11,332 shares of the Company’s common stock at an exercise price of $8.824 per share with a ten-year life, expiring December 4, 2028 (“December 2018 Warrants”). The December 2018 Warrants were valued using the Black-Scholes option pricing model with the following assumptions: volatility of 80.09%, expected term of ten years, risk-free interest rate of 2.98%, and a zero-dividend yield. The collective warrant fair value of approximately $0.1 million has been recorded as a debt discount and is being amortized through interest expense using the effective interest method through the scheduled maturity date, as amended and described above. Summary of Carrying Value The following table summarizes the components of the debt facility carrying value, which approximates the fair value (in thousands): As of September 30, 2019 Short-term Long-term Principal payments to lender and end of term charge $ — $ 25,341 Debt issuance costs — (202 ) Debt discount related to warrants — (177 ) Carrying Value $ — $ 24,962 The carrying value of the debt facility approximates fair value. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 7. Fair Value Measurements The Company measures and reports certain financial instruments at fair value on a recurring basis and evaluates its financial instruments subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them in each reporting period. The Company determined that certain investments in debt securities classified as available-for-sale securities were Level 1 financial instruments. Additional investments in corporate debt securities, commercial paper, and asset-backed securities are considered Level 2 financial instruments because the Company has access to quoted prices but does not have visibility to the volume and frequency of trading for all of these investments. For the Company’s investments, a market approach is used for recurring fair value measurements and the valuation techniques use inputs that are observable, or can be corroborated by observable data, in an active marketplace. Foreign exchange derivatives not designated as hedging instruments are considered Level 2 financial instruments. The Company’s foreign exchange derivative instruments are typically short-term in nature. The Company also determined that the contingent consideration, as settled in full during the second quarter of 2019, was a Level 3 financial instrument. The fair value of these instruments as of September 30, 2019 and December 31, 2018 was as follows (in thousands Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) As of September 30, 2019: Cash equivalents: U.S. Treasury money market funds $ 5,109 $ — $ — Repurchase agreements $ 8,000 Short-term investments: U.S. government securities $ 28,496 $ — $ — Asset backed securities $ — $ 8,807 $ — Corporate securities $ — $ 31,811 $ — Commercial paper $ — $ 19,382 $ — Liabilities: Foreign exchange derivatives not designated as hedging instruments $ — $ 136 $ — As of December 31, 2018: Cash equivalents: U.S. Treasury money market funds $ 14,710 $ — $ — Commercial paper $ — $ 4,411 $ — Corporate securities $ — $ 2,371 $ — Short-term investments: U.S. government securities $ 15,965 $ — $ — Asset backed securities $ 8,588 Corporate securities $ — $ 19,954 $ — Commercial paper $ — $ 42,022 $ — Liabilities: Contingent consideration $ — $ — $ 12,214 Foreign exchange derivatives not designated as hedging instruments $ — $ 26 $ — The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments (in thousands) for the nine months ended September 30, 2019 and year ended December 31, 2018: Contingent Consideration As of December 31, 2017 $ 11,948 Change in fair value 266 Balance at December 31, 2018 $ 12,214 Change in fair value 219 Settlement of contingent liability (12,433 ) Balance at September 30, 2019 $ — Prior to its settlement in May 2019, the Company recorded changes in fair value of the contingent consideration in general and administrative expense. The Company did not transfer any assets measured at fair value on a recurring basis to or from Level 1, Level 2, and Level 3 during the nine months ended September 30, 2019 and year ended December 31, 2018. |
Derivative Financial Instrument
Derivative Financial Instruments | 9 Months Ended |
Sep. 30, 2019 | |
Derivative Instruments And Hedging Activities Disclosure [Abstract] | |
Derivative Financial Instruments | 8. Derivative Financial Instruments In the normal course of business, the Company is exposed to the impact of foreign currency fluctuations. The Company seeks to limit these risks by following risk management policies and procedures, including the use of derivatives. The Company’s derivative contracts, which are not designated as hedging instruments, principally address short-term foreign currency exchange. The estimated fair value of the derivative contracts was based upon the relative exchange rate as of the balance sheet date. Accordingly, any gains or losses resulting from variances between this exchange rate and the exchange rate at the contract inception date were recognized in “Other income, net” in the condensed consolidated statements of operations and comprehensive loss. As of September 30, 2019, there was an asset of approximately $3.0 million consisting of unsettled forward exchange contracts to purchase foreign currency and a corresponding liability of approximately $3.1 million consisting of forward exchange contract obligations, resulting in a net derivative financial instrument of approximatley $0.1 million, recorded at their estimated fair value in “Accrued expenses and other current liabilities.” |
Shareholders' Equity
Shareholders' Equity | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Shareholders' Equity | 9. Shareholders’ Equity Common Stock Sales Agreement On April 28, 2017, the Company entered into a Common Stock Sales Agreement with H.C. Wainwright & Co., LLC (“Wainwright”), as sales agent, which was amended by Amendment No. 1 to the Common Stock Sales Agreement (the “Amendment”) on June 29, 2018 (the “Sales Agreement”), pursuant to which the Company may offer and sell, from time to time, through Wainwright, shares of Savara’s common stock, par value $0.001 per share (the “Shares”), having an aggregate offering price of not more than $60.0 million, in addition to the $2.3 million in shares sold prior to the Amendment. The Amendment was effective on July 13, 2018, the date the Company’s new shelf registration agreement on Form S-3, as filed with the Securities and Exchange Commission on June 29, 2018, was declared effective (“New Registration Statement”) by the Securities and Exchange Commission. The Shares will be offered and sold pursuant to the New Registration Statement. Subject to the terms and conditions of the Sales Agreement, Wainwright will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. The Company has provided Wainwright with customary indemnification rights, and Wainwright will be entitled to a commission at a fixed commission rate equal to 3.0% of the gross proceeds per Share sold. Sales of the Shares, if any, under the Sales Agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended. The Company has no obligation to sell any of the Shares and may at any time suspend sales under the Sales Agreement or terminate the Sales Agreement . During the nine months ended September 30, 2019, the Company sold 4,769,726 shares of common stock under the Sales Agreement, for net proceeds of approximately $29.6 million. Common Stock The Company’s amended and restated certificate of incorporation authorizes the Company to issue 201 million shares of common and preferred stock, consisting of 200 million shares of common stock with $0.001 par value and one million shares of preferred stock with $0.001 par value. The following is a summary of the Company’s common stock at September 30, 2019 and December 31, 2018. September 30, 2019 December 31, 2018 Common stock authorized 200,000,000 200,000,000 Common stock outstanding 41,208,261 35,146,096 The Company’s shares of common stock reserved for issuance as of September 30, 2019 and December 31, 2018 were as follows: September 30, 2019 December 31, 2018 Warrants acquired in merger 718,373 750,840 Warrants converted pursuant to merger 72,869 72,869 April 2017 SVB Warrants 24,725 24,725 June 2017 SVB Warrants 41,736 41,736 December 2018 SVB Warrants 11,332 11,332 Pre-funded warrants 775,000 775,000 Stock options outstanding 3,247,910 3,077,264 Issued and nonvested RSU's 128,375 156,250 Total shares reserved 5,020,320 4,910,016 Warrants The following table summarizes the outstanding warrants for the Company’s common stock as of September 30, 2019: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 314,446 $ 52.50 November 2019 403,927 $ 29.40 February 2021 72,869 $ 8.98 June 2021 775,000 $ 0.01 October 2024 24,725 $ 9.10 April 2027 41,736 $ 5.39 June 2027 11,332 $ 8.824 December 2028 1,644,035 |
Commitments and Settlement
Commitments and Settlement | 9 Months Ended |
Sep. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Settlement | 10. Commitments and Settlement Operating Leases We are obligated under operating leases and subleases for office space. On November 29, 2017, we entered into a sublease agreement for office space for our corporate headquarters in Austin, Texas. The term of the sublease commenced on January 1, 2018 and will continue until July 31, 2021, with annual rental payments of approximately $0.2 million, paid over monthly installments, subject to increases of approximately 2% annually on the anniversary of the commencement date of the sublease term. However, monthly base rent for the first month of the sublease term was abated. We lease office space in Copenhagen, Denmark under a lease with an effective date of November 1, 2018 and that expires on September 30, 2022. The lease in Copenhagen can be terminated by the lessee and lessor no earlier than March 31, 2022 for vacating the premises by September 30, 2022 and contains an option to extend the lease term to remain in force until it is terminated in writing by either the lessee or lessor with a six month notice period from the first day of the month following September 30, 2022. For the nine months ended September 30, 2019, it is not reasonably certain the Company will exercise the extension options inherent in the lease. Our annual rent is approximately $0.1 million, paid over monthly installments, subject to annual increases equal to the Danish consumer price index, or approximately 2% annually. On March 23, 2017, we sublet office space located in San Diego, California with rentable office space of approximately 13,707 square feet, which previously served as a predecessor’s corporate headquarters, to a third party as the Company no longer had an ongoing need for this facility. The term of the sub-sublease commenced on July 1, 2017 and expires on May 31, 2020, coterminous with a sublease agreement dated June 19, 2014 with the sublessor. As of September 30, 2019, annual rent under the sub-sublease is approximately $0.5 million, payable in monthly installments. We previously leased office space for our corporate headquarters in Austin, Texas, pursuant to an operating lease dated November 19, 2012, as amended May 22, 2015, under which we are obligated to remit annual rental payments of approximately $0.1 million payable in monthly installments for the period January 1, 2018 through November The following is a maturity analysis of the annual undiscounted cash flows reconciled to the carrying value of the operating lease liabilities as of September 30, 2019 (in thousands): Year ending December 31, 2019 $ 200 2020 478 2021 184 2022 67 Total future minimum lease payments $ 929 Less imputed interest (57 ) Total $ 872 For the three months ended September 30, 2019 For the nine months ended September 30, 2019 Lease cost: Operating lease cost $ 376 $ 1,117 Sublease income (153 ) (461 ) Total lease cost $ 223 $ 656 Other information: Operating cash flows from operating leases $ 198 $ 587 Weighted-average remaining lease term (in months) - operating leases 19.9 19.9 Weighted-average discount rate - operating leases 8.5 % 8.5 % As of September 30, 2019, the carrying value of the right-of-use assets for the operating leases was $0.8 million, which is reflected in “Other non-current assets,” and the carrying value of the lease liabilities for operating leases was $0.9 million, of which $0.6 million related to the current portion of the lease liabilities is recorded in “Accrued expenses and other current liabilities,” and $0.3 million related to the non-current portion of the lease liabilities is recorded in “Other long-term liabilities.” Risk Management The Company maintains various forms of insurance that the Company's management believes are adequate to reduce the exposure to certain risks associated with operating the Company’s business to an acceptable level. Employment Agreements Certain executive officers are entitled to payments if they are terminated without cause or resign for good reason (each as defined in the employment agreements). Upon termination without cause, and not as a result of death or disability or resignation for good reason, each of such officers is entitled to receive a payment of base salary for twelve months and a pro-rated portion of their unpaid bonus following termination of employment, and such officer will be entitled to continue to receive coverage under medical and dental benefit plans for twelve months or until such officer is covered under a separate plan from another employer. Upon a termination other than for cause or resignation for good reason within twelve months following a change in control, each of such officers is entitled to receive a payment of base salary for eighteen months and one-hundred percent of their unpaid bonus following termination of employment and such officer will be entitled to continue to receive coverage under medical and dental benefit plans for twelve months or until such officer is covered under a separate plan from another employer and will also be entitled to certain acceleration of such officer’s outstanding nonvested options at the time of such termination. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 11. Stock-Based Compensation A. Equity Incentive Plan 2008 Stock Option Plan The Company adopted the Savara Inc. Stock Option Plan (the “2008 Plan”), pursuant to which the Company had reserved shares for issuance to employees, directors, and consultants. The 2008 Plan includes (i) the option grant program providing for both incentive and non-qualified stock options, as defined by the Internal Revenue Code, and (ii) the stock issuance program providing for the issuance of awards that are valued based upon common stock, including restricted stock, dividend equivalents, stock appreciation rights, phantom stock, and performance units. The 2008 Plan also allows eligible persons to purchase shares of common stock at an amount determined by the plan administrator. Upon a participant’s termination, the Company retains the right to repurchase nonvested shares issued in conjunction with the stock issuance program at the fair market value per share as of the date of termination. The Company had previously issued incentive and non-qualified options and restricted stock to employees and non-employees under the 2008 Plan. The terms of the stock options, including the exercise price per share and vesting provisions, were determined by the board of directors. Stock options were granted at exercise prices not less than the estimated fair market value of the Company’s common stock at the date of grant based upon objective and subjective factors including: third-party valuations, preferred stock transactions with third parties, current operating and financial performance, management estimates and future expectations. Stock option grants typically vest quarterly over three to four years and expire ten years from the grant date, and restricted stock grants vest on a quarterly basis over four years and expire ten years from the grant date. The Company no longer issues stock-based awards under the 2008 Plan. 2015 Omnibus Incentive Option Plan The Company operates the 2015 Omnibus Incentive Plan (the “2015 Plan”), which was amended and approved by stockholders in June 2018. The 2015 Plan provides for the grant of incentive and non-statutory stock options, as well as share appreciation rights, restricted shares, restricted stock units, performance units, shares and other stock-based awards. Share-based awards are subject to terms and conditions established by our board of directors or the compensation committee of our board of directors. As of September 30, 2019, the number of shares of our common stock available for grant under the 2015 Plan was 1,265,733 shares. B. Stock Option and Restricted Stock Units The Company values stock options using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including the risk-free interest rate, expected life, expected stock price volatility, and dividend yield. The risk-free interest rate assumption is based upon observed interest rates for constant maturity U.S. Treasury securities consistent with the expected term of the Company’s employee stock options. The expected life represents the period of time the stock options are expected to be outstanding and is based on the simplified method. The Company uses the simplified method due to the lack of sufficient historical exercise data to provide a reasonable basis upon which to otherwise estimate the expected life of the stock options. Expected volatility is based on historical C. Stock-Based Award Activity The following table provides a summary of stock-based awards for the 2008 Plan and 2015 Plan for the nine months ended September 30, 2019 and 2018: Nine months ended September 30, 2019 Nine months ended September 30, 2018 Stock Options RSUs Total Stock Options RSUs Total Outstanding as of December 31 3,077,264 156,250 3,233,514 1,916,832 86,875 2,003,707 Granted 347,125 34,000 381,125 1,016,720 120,000 1,136,720 Exercised (136,729 ) (39,375 ) (176,104 ) (175,407 ) (37,500 ) (212,907 ) Forfeited (39,750 ) (22,500 ) (62,250 ) (123,850 ) — (123,850 ) Outstanding as of September 30 3,247,910 128,375 3,376,285 2,634,295 169,375 2,803,670 D. Stock-Based Compensation Stock-based compensation expense is included in the following line items in the accompanying statements of operations and comprehensive loss for the three and nine months ended September 30, 2019 and 2018 (in thousands): Three Months Ended Nine Months Ended September 30, 2019 September 30, 2018 September 30, 2019 September 30, 2018 Research and development $ 570 $ 813 $ 1,565 $ 1,186 General and administrative 576 1,175 1,727 1,606 Total stock-based compensation $ 1,146 $ 1,988 $ 3,292 $ 2,792 |
License Agreement
License Agreement | 9 Months Ended |
Sep. 30, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
License Agreement | 12. License Agreement The Company entered into a license agreement on May 12, 2016, as amended on June 4, 2018 (the “License Agreement”), with a licensee under which the licensee received an exclusive right to import, market, sell, distribute and promote Molgradex in Japan for the treatment of aPAP. In return, the licensee will pay the Company marketing and regulatory-based milestone payments and sales-based royalties. In October 2018, the Company achieved a milestone payment pursuant to the License Agreement resulting in the receipt of $0.3 million from the licensee. As of September 30, 2019, the Company has determined that it has not met all of the performance obligations under the License Agreement and, accordingly, has recorded the milestone payment as deferred revenue in “Other long-term liabilities” in the Company’s condensed consolidated balance sheet until such time the performance obligations are met. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 13. Net Loss per Share Basic and diluted net loss per share is computed by dividing net loss by the weighted-average number of common stock outstanding during the period. For periods in which the Company generated a net loss, the Company does not include the potential impact of dilutive securities in diluted net loss per share, as the impact of these items is anti-dilutive. The following weighted-average equity instruments were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented: Nine Months Ended September 30, 2019 September 30, 2018 Awards under equity incentive plan 3,247,910 2,634,295 Nonvested restricted shares and restricted stock units 128,375 173,422 Warrants to purchase common stock 869,035 890,170 Total 4,245,320 3,697,887 The following table reconciles basic earnings per share of common stock for the three and nine months ended September 30, 2019 and 2018: Three Months Ended Nine Months Ended September 30, 2019 September 30, 2018 September 30, 2019 September 30, 2018 Net loss $ (12,403 ) $ (12,560 ) $ (46,454 ) $ (51,002 ) Net loss attributable to common stockholders (12,403 ) (12,560 ) (46,454 ) (51,002 ) Undistributed earnings and net loss attributable to common stockholders, basic and diluted (12,403 ) (12,560 ) (46,454 ) (51,002 ) Weighted average common shares outstanding, basic and diluted 41,727,259 34,483,563 38,749,002 32,423,510 Basic and diluted EPS $ (0.30 ) $ (0.36 ) $ (1.20 ) $ (1.57 ) |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | 14. Subsequent Events On October 1, 2019, the Company received a written response from the FDA regarding the Molgradex development program for the treatment of aPAP and the related results from the Phase 3 study previously disclosed by the Company on June 12, 2019. In the written response, the FDA indicated that the data provided in the briefing package for the Type C meeting did not provide sufficient evidence of efficacy and safety. Following the Company’s public announcement of the response from the FDA on October 2, 2019, the Company’s stock price experienced a significant decline and has not recovered from this decline. Accordingly, the Company determined that a triggering event had occurred requiring the impairment testing of its goodwill. In accordance with its policies, the Company performed a quantitative calculation of measuring the goodwill impairment loss by comparing the implied fair value of its reporting unit’s goodwill with the carrying amount of that goodwill which resulted in an impairment charge of $19.4 million in the fourth quarter of 2019 reducing the Company’s carrying value of its goodwill to its fair value, which was determined to be zero. Similarly, the Company completed a qualitative and quantitative impairment testing of its IPR&D following this fourth quarter 2019 triggering event and concluded that there was no impairment to its IPR&D. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The interim condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”) as defined by the Financial Accounting Standards Board (“FASB”). These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2018. Certain prior period amounts have been reclassified for consistency with current period presentation. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The interim condensed consolidated financial statements included in this document are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for a fair statement of the Company’s financial position as of September 30, 2019, and its results of operations for the three and nine months ended September 30, 2019 and 2018, and cash flows for the nine months ended September 30, 2019 and 2018. The results of operations for interim periods shown in this report are not necessarily indicative of the results to be expected for the year ending December 31, 2019 or for any other future annual or interim period. The December 31, 2018 consolidated balance sheet was derived from audited financial statements but does not include all disclosures required by U.S. GAAP. These condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2018. |
Liquidity | Liquidity As of September 30, 2019, the Company had an accumulated deficit of approximately $176.2 million. The Company also had negative cash flow from operations of approximately $35.2 million during the nine months ended September 30, 2019. The cost to further develop and obtain regulatory approval for any drug is substantial and, as noted below, the Company may have to take certain steps to maintain a positive cash position. Accordingly, the Company will need additional capital to further fund the development of, and seek regulatory approvals for, its product candidates and begin to commercialize any approved products. Currently, the Company is primarily focused on the development of respiratory drugs and believes such activities will result in the Company’s continued incurrence of significant research and development and other expenses related to those programs. If the clinical trials for any of the Company’s product candidates fail or produce unsuccessful results and those product candidates do not gain regulatory approval, or if any of the Company’s product candidates, if approved, fail to achieve market acceptance, the Company may never become profitable. Even if the Company achieves profitability in the future, it may not be able to sustain profitability in subsequent periods. The Company intends to cover its future operating expenses through cash and cash equivalents on hand and through a combination of equity offerings, debt financings, government or other third-party funding, and other collaborations and strategic alliances. The Company cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to the Company or its stockholders. While the Company had cash and cash equivalents of $17.8 million and short-term investments of $88.5 million as of September 30, 2019, the Company intends to continue to raise additional capital as needed through the issuance of additional equity securities and potentially through borrowings, and strategic alliances with partner companies. However, if such financings are not available timely and at adequate levels, the Company will need to reevaluate its operating plans. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
Principles of Consolidation | Principles of Consolidation The interim condensed consolidated financial statements of the Company are stated in U.S. dollars and are prepared using U.S. GAAP. These financial statements include the accounts of the Company and its wholly owned subsidiaries. The financial statements of the Company’s wholly owned subsidiaries are recorded in their functional currency and translated into the reporting currency. The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in “Accumulated other comprehensive income (loss).” All intercompany transactions and accounts have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Management’s estimates include those related to the accrual of research and development and general and administrative costs, certain financial instruments recorded at fair value, stock-based compensation, and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that it believes to be reasonable under the circumstances. Accordingly, actual results could be materially different from those estimates. |
Risks and Uncertainties | Risks and Uncertainties The product candidates being developed by the Company require approvals from the U.S. Food and Drug Administration (“FDA”) or foreign regulatory agencies prior to commercial sales. There can be no assurance that the Company’s product candidates will receive the necessary approvals. If the Company is denied regulatory approval of its product candidates, or if approval is delayed, it may have a material adverse impact on the Company’s business, results of operations, and its financial position. The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the successful discovery and development of drug candidates, raising additional capital, development of competing drugs and therapies, protection of proprietary technology, and market acceptance of the Company’s products. As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash and institutional bank money market accounts with original maturities of three months or less when acquired and are stated at cost, which approximates fair value. |
Short-term Investments | Short-term Investments The Company has classified its investments in debt securities with readily determinable fair value as available-for-sale securities. These securities are carried at estimated fair value with the aggregate unrealized gains and losses related to these investments reflected as a part of “Accumulated other comprehensive income The fair value of the investments is based on the specific quoted market price of the securities or comparable securities at the balance sheet dates. Investments in debt securities are considered to be impaired when a decline in fair value is judged to be other than temporary because the Company either intends to sell or it is more-likely-than not that it will have to sell the impaired security before recovery. Once a decline in fair value is determined to be other than temporary, an impairment charge is recorded and a new cost basis in the investment is established. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash and cash equivalents and foreign exchange derivatives not designated as hedging. The Company places its cash and cash equivalents with a limited number of high-quality financial institutions and at times may exceed the amount of insurance provided on such deposits. |
Accrued Research and Development Costs | Accrued Research and Development Costs The Company records the costs associated with research, nonclinical studies, clinical trials, and manufacturing development as incurred. These costs are a significant component of the Company’s research and development expenses, with a substantial portion of the Company’s on-going research and development activities conducted by third-party service providers, including contract research and manufacturing organizations. The Company accrues for expenses resulting from obligations under agreements with contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and other outside service providers for which payment flows do not match the periods over which materials or services are provided to the Company. Accruals are recorded based on estimates of services received and efforts expended pursuant to agreements established with CROs, CMOs, and other outside service providers. These estimates are typically based on contracted amounts applied to the proportion of work performed and determined through analysis with internal personnel and external service providers as to the progress or stage of completion of the services. The Company makes significant judgments and estimates in determining the accrual balance in each reporting period. In the event advance payments are made to a CRO, CMO, or outside service provider, the payments will be recorded as a prepaid asset which will be amortized or expensed as the contracted services are performed. As actual costs become known, the Company adjusts its prepaids and accruals. Inputs, such as the services performed, the number of patients enrolled, or the study duration, may vary from the Company’s estimates resulting in adjustments to research and development expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations. To date, the Company has not experienced any material deviations between accrued and actual research and development expenses. |
Business Combinations | Business Combinations Assets acquired and liabilities assumed as part of a business acquisition are recorded at their estimated fair value at the date of acquisition. The excess of purchase price over the fair value of assets acquired and liabilities assumed is recorded as goodwill. Determining fair value of identifiable assets, particularly intangibles, and liabilities acquired also requires management to make estimates, which are based on available information and, in some cases, assumptions with respect to the timing and amount of future revenue and expenses associated with an asset. |
Goodwill and Acquired In-Process Research and Development, and Deferred Tax Liability | Goodwill, Acquired In-Process Research and Development, and Deferred Tax Liability Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company. Goodwill is not amortized, but assessed for impairment on an annual basis or more frequently if impairment indicators exist. Current guidance issued by the FASB, as previously adopted by the Company, provides an impairment model whereby the Company has the option to implement a one-step method for determining impairment of goodwill, simplifying the subsequent measurement of goodwill by eliminating Step 2 (quantitative calculation of measuring a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill) from the goodwill impairment test. Under the amendments in this guidance, an entity should perform its annual goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, an entity should consider income tax effects from any tax-deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment loss, if applicable. Acquired in-process research and development (“IPR&D”) is considered an indefinite-lived intangible asset and is assessed for impairment annually or more frequently if impairment indicators exist. The Company adopted accounting guidance related to its annual acquired IPR&D impairment test, a two-step method, which allows the Company to first assess qualitative factors before performing a quantitative assessment of the fair value of a reporting unit. If it is determined on the basis of qualitative factors that the fair value of the IPR&D is more likely than not less than the carrying amount, a quantitative impairment test is required. If the associated research and development effort is abandoned, the related asset will be written-off, and the Company will record a noncash impairment loss on its consolidated statements of operations and comprehensive loss. For those products that reach commercialization, the IPR&D asset will be amortized over its estimated useful life. The Company performs its annual goodwill impairment test and IPR&D impairment test, as described above, as of June 30th and September 30th, respectively, or whenever an event or change in circumstances occurs that would require reassessment of the recoverability of those assets. For the nine months ended September 30, 2019, the Company experienced no change in the carrying value of goodwill and a decrease of approximately $0.6 million in the carrying value of IPR&D, which was due to foreign currency translation. Due to the Company’s current carrying value, if we experience material declines in our stock price, goodwill impairment may occur. For instance, the Company determined that a triggering event had occurred during the fourth quarter of 2019 under which the Company’s stock price experienced a significant decline requiring the impairment testing of its goodwill which will result in an impairment charge of $19.4 million in the fourth quarter of 2019 reducing the Company’s carrying value of its goodwill to its fair value, which was determined to be zero (See Note 14). Similarly, the Company completed the aforementioned qualitative and quantitative impairment testing of its IPR&D following this fourth quarter 2019 triggering event and concluded that there was no impairment to its IPR&D. |
Tax Credit Receivable | Tax Credit Receivable The Company has recorded a Danish tax credit earned by its subsidiary, Savara ApS, as of September 30, 2019. Under Danish tax law, Denmark remits a research and development tax credit equal to 22% of qualified research and development expenditures, not to exceed established thresholds. As of September 30, 2019, credits totaling $1.6 million had been generated but not yet received. Of this total Danish tax credit, $0.8 million is related to research and development activities incurred during the year ended December 31, 2018 and is recorded in “Prepaid expenses and other current assets” and expected to be received in the fourth quarter of 2019. The remaining portion of the Danish tax credit of $0.8 million, which was generated during the nine months ended September 30, 2019, is recorded in “Other non-current assets” and is expected to be received in the fourth quarter of 2020. The Company also recognized tax credit income for the nine months ended September 30, 2019 as provided by the Australian Taxation Office for qualified research and development expenditures incurred through our subsidiary, Savara Australia Pty. Limited. Under Australian tax law, Australia remits a research and development tax credit equal to 43.5% of qualified research and development expenditures, not to exceed established thresholds. As of September 30, 2019, credits totaling $0.3 million had been generated but not yet received and such amount is recorded in “Prepaid expenses and other current assets” with expectation of receipt in the first half of the year ending December 31, 2020. |
Leases | Leases In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases (Topic 842)” (“ASU 2016-02”) as codified in Accounting Standards Codification (“ASC”) No. 842 (“ASC 842”). ASU 2016-02, ASC 842, and additional issued guidance are intended to improve financial reporting of leasing transactions by requiring organizations that lease assets to recognize assets and liabilities for the rights and obligations created by leases that extend more than twelve months. This accounting update also requires additional disclosures surrounding the amount, timing, and uncertainty of cash flows arising from leases. ASU 2016-02 is effective for financial statements issued for annual and interim periods beginning after December 15, 2018 for public business entities. The Company adopted ASU 2016-02 as of January 1, 2019 using the effective date transition method of implementation offered under ASU 2018-11, “Leases (Topic 842) – Targeted Improvements” issued in July 2018 (“ASU 2018-11”), under which entities may change their date of initial application of ASU 2016-02 to the beginning of the period of adoption, or January 1, 2019, in the case of Savara. Accordingly, the Company is required to apply the prior lease guidance pursuant to ASC Topic 840 in the comparative periods, provide the disclosures required by ASC Topic 840 for all periods that continue to be presented in accordance with ASC Topic 840, recognize the effects of applying ASC 842 as a cumulative-effect adjustment to retained earnings as of January 1, 2019, if any, and provide certain disclosures under ASC 842 (see Note 10). The Company has also elected the package of practical expedients, applied by class of underlying asset, permitted in ASU 2018-11. Accordingly, the Company accounted for its existing operating leases as operating leases under the new guidance, without reassessing (a) whether the contracts contain a lease under ASC 842, (b) whether classification of the operating leases would be different in accordance with ASC 842, and (c) whether the unamortized initial direct costs before transition adjustments (as of the period of adoption) would have met the definition of initial direct costs in ASC 842 at lease commencement, and the Company did not separate lease and non-lease components. As a result of the adoption of the new lease accounting guidance using the effective date transition method, on January 1, 2019, the Company recognized (a) a lease liability of approximately $1.4 million, which represents the present value of the remaining lease payments, as of the date of adoption, of approximately $1.5 million, discounted using the Company’s incremental borrowing rate of 8.5%, and (b) a right-of-use asset of approximately $1.4 million. The adoption of the new standard did not result in any adjustment to the Company’s retained earnings as of January 1, 2019. The adoption of this standard did not have a material impact on the Company’s condensed consolidated balance sheets, cash used/provided from operating, investing, or financing activities in the condensed consolidated statements of cash flows, or on the Company’s operating results. The most significant impact was the recognition of right-of-use assets for operating leases, which are reflected in “Other non-current assets,” and lease liabilities for operating leases, which are reflected in “Accrued expenses and other current liabilities,” for the current portion of the lease liabilities, and in “Other long-term liabilities” for the non-current portion of the lease liabilities, respectively (See Note 10). |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. Our chief operating decision maker is the chief executive officer. We have one operating segment, specialty pharmaceuticals within the respiratory system. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability. The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value. The three tiers are defined as follows: • Level 1 – Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets; • Level 2 – Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and • Level 3 – Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions. Financial instruments carried at fair value include cash and cash equivalents, short-term investments, contingent consideration, prior to its settlement and full satisfaction in May 2019, and foreign exchange derivatives not designated as hedging instruments. Financial instruments not carried at fair value include accounts payable and accrued liabilities. The carrying amounts of these financial instruments approximate fair value due to the highly liquid nature of these short-term instruments. |
Revenue Recognition | Revenue Recognition The Company will record revenue based on a five-step model in accordance with ASC 606, “Revenue from Contracts with Customers.” To date, the Company has not generated any product revenue from its drug candidates. The Company’s ability to generate product revenues, which the Company does not expect will occur in the near term, if ever, will depend heavily on the successful development, regulatory approval, and eventual commercialization of the Company’s product candidates. |
Milestone Revenue | Milestone Revenue The Company is subject to a license agreement related to its Molgradex product candidate (see Note 12), which includes certain milestone payments to be remunerated by the licensee to Savara. Pursuant to the license agreement, the Company identifies the performance obligations, determines the transaction price, allocates the contract transaction price to the performance obligations, and recognizes the revenue when (or as) the performance obligation is satisfied. The Company identifies the performance obligations included within the license agreement and evaluates which performance obligations are distinct. The milestone payments are a form of variable consideration as the payments are contingent upon achievement of a substantive event. The milestone payments are estimated and included in the transaction price when the Company determines, under the variable consideration constraint, that it is probable that there will not be a significant reversal of cumulative revenue recognized in future periods. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts the estimate of the overall transaction price. |
Net Loss per Share | Net Loss per Share Basic net loss attributable to common stockholders per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock and pre-funded warrants outstanding during the period without consideration of common stock equivalents. Since the Company was in a loss position for all periods presented, diluted net loss per share is the same as basic net loss per share for all periods presented as the inclusion of all potential dilutive securities would have been antidilutive. |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes the cost of stock-based awards granted to employees based on the estimated grant-date fair value of the awards. The value of the portion of the award that is ultimately expected to vest is recognized as expense ratably over the requisite service period. The Company recognizes the compensation costs for awards that vest over several years on a straight-line basis over the vesting period (see Note 11). Forfeitures are recognized when they occur, which may result in the reversal of compensation costs in subsequent periods as the forfeitures arise. |
Manufacturing and Other Commitments and Contingencies | Manufacturing and Other Commitments and Contingencies The Company is subject to various manufacturing royalties and payments related to its product candidate, Molgradex. Under a manufacture and supply agreement with the active pharmaceutical ingredients (“API”) manufacturer, Savara must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below. Additionally, upon first receipt of marketing approval by Savara from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, Savara shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country. Pursuant to a license agreement (see Note 12) between the Company and a Japanese licensee regarding the development and commercialization of Molgradex for the treatment of aPAP in Japan, the Company shall fund the licensee fifty percent (50%), up to a maximum of approximately $0.8 million, of the external costs associated with specific regulatory and filing activities to be conducted by the licensee. As of September 30, 2019, no costs have been incurred. Under an agreement with a medical education and research foundation entered into on October 8, 2018, the Company is subject to a milestone payment for the use of proprietary information and material in intellectual property filings related to the application of Molgradex in the treatment of NTM. The Company will owe royalties to the foundation based on net sales of Molgradex for the treatment of NTM equal to one half of one percent (0.5%) after publication of the intellectual property filings and one quarter of one percent (0.25%) prior to the publication or in the event publication does not occur, with respect to the specified intellectual property filings. The Company is also subject to certain contingent milestone payments, disclosed in the following table, payable to the manufacturer of the nebulizer used to administer Molgradex. The change in the amount of the milestone payments from June 30, 2019 to September 30, 2019 was solely related to changes in foreign currency exchange rates. In addition to these milestones, the Company will owe a royalty to the manufacturer of the nebulizer based on net sales. The royalty rate ranges from three and one half percent (3.5%) to five percent (5%) depending on the device technology used by the Company to administer the product. Manufacturing and Other Contingent Milestone and Co-Development Payments (in thousands): September 30, 2019 Molgradex API manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of Molgradex $ 2,600 Molgradex nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized to administer Molgradex 7,417 Molgradex Japanese licensee: Co-marketing and regulatory costs 750 Medical education and research foundation: First commercial sale in the U.S. of Molgradex in treatment of NTM 500 Total manufacturing and other commitments $ 11,267 The milestones and co-marketing commitments disclosed above reflect the activities that have (i) not been met or incurred; (ii) not been remunerated; and (iii) not accrued, as the activities are not deemed probable or reasonably estimable, as of September 30, 2019. |
Income Taxes | Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of a change in tax rates on deferred tax assets and liabilities will be recognized in the period that includes the enactment date. A valuation allowance is established against the deferred tax assets to reduce their carrying value to an amount that is more likely than not to be realized. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In August 2018, the FASB issued ASU 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurement.” The update eliminates, adds, and modifies certain disclosure requirements for fair value measurements as part of its disclosure framework project. ASU 2018-13 is effective for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years, with early adoption permitted. The Company has not adopted ASU 2018-13 and is currently evaluating its impact on our condensed consolidated financial statements. In November 2018, the FASB issued ASU 2018-18, “Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606.” The update clarifies that certain transactions between collaborative partners should be accounted for as revenue under the new revenue standard ASC 606 when the collaborative partner is a customer, specifies the unit of account for determining whether a transaction with a customer is a distinct good or service under ASC 606, and precludes a company from presenting transactions with a collaborative partner that are not in the scope of ASC 606 together with revenue from contracts with customers. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years, with early adoption permitted. The Company has reviewed ASU 2018-18 and concluded that it has no impact on our condensed consolidated financial statements. In March 2019, the FASB issued ASU 2019-01, “Leases (Topic 842): Codification Improvements,” which aims to clarify and revise guidance for certain lessors and clarify interim transition disclosure requirements for ASC 842. ASU 2019-01 is effective for fiscal years beginning after December 15, 2019 and for interim periods within those fiscal years, with early adoption permitted. The Company has not yet adopted ASU 2019-01 and is currently evaluating its impact on our condensed consolidated financial statements. In April 2019, the FASB issued ASU 2019-04, “Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments.” The Company has reviewed ASU 2019-01 and concluded that it has no impact on our condensed consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Manufacturing and Other Contingent Milestone and Co-Development Payments | Manufacturing and Other Contingent Milestone and Co-Development Payments (in thousands): September 30, 2019 Molgradex API manufacturer: Achievement of certain milestones related to validation of API and regulatory approval of Molgradex $ 2,600 Molgradex nebulizer manufacturer: Achievement of various development activities and regulatory approval of nebulizer utilized to administer Molgradex 7,417 Molgradex Japanese licensee: Co-marketing and regulatory costs 750 Medical education and research foundation: First commercial sale in the U.S. of Molgradex in treatment of NTM 500 Total manufacturing and other commitments $ 11,267 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses consisted of (in thousands): September 30, 2019 December 31, 2018 R&D tax credit receivable $ 1,140 $ 1,263 Prepaid contracted research and development costs 319 561 VAT receivable 265 421 Prepaid insurance 74 162 Deposits and other 267 107 Total prepaid expenses and other current assets $ 2,065 $ 2,514 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Payables And Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of (in thousands): September 30, 2019 December 31, 2018 Accrued contracted research and development costs $ 3,210 $ 2,044 Accrued general and administrative costs 301 371 Accrued compensation 1,177 643 Foreign currency exchange derivative 136 26 Deferred revenue — 250 Lease liability 564 — Other — 41 Total accrued expenses and other current liabilities $ 5,388 $ 3,375 |
Short-term Investments (Tables)
Short-term Investments (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Major Security Type of Investments | The following table summarizes, by major security type, the Company’s investments (in thousands): As of September 30, 2019: Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 28,475 $ 21 $ — $ 28,496 Asset backed securities 8,791 16 — 8,807 Corporate securities 31,745 66 — 31,811 Commercial paper 19,382 — — 19,382 Total short-term investments $ 88,393 $ 103 $ — $ 88,496 As of December 31, 2018: Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Short-term investments U.S. government securities $ 15,967 $ — $ (2 ) $ 15,965 Asset backed securities 8,595 — (7 ) 8,588 Corporate securities 19,975 — (21 ) 19,954 Commercial paper 42,022 — — 42,022 Total short-term investments $ 86,559 $ — $ (30 ) $ 86,529 |
Debt Facility (Tables)
Debt Facility (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Summary of Components of Debt Facility Carrying Value | The following table summarizes the components of the debt facility carrying value, which approximates the fair value (in thousands): As of September 30, 2019 Short-term Long-term Principal payments to lender and end of term charge $ — $ 25,341 Debt issuance costs — (202 ) Debt discount related to warrants — (177 ) Carrying Value $ — $ 24,962 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Summary of Fair Value of Financial Instruments | The fair value of these instruments as of September 30, 2019 and December 31, 2018 was as follows (in thousands Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) As of September 30, 2019: Cash equivalents: U.S. Treasury money market funds $ 5,109 $ — $ — Repurchase agreements $ 8,000 Short-term investments: U.S. government securities $ 28,496 $ — $ — Asset backed securities $ — $ 8,807 $ — Corporate securities $ — $ 31,811 $ — Commercial paper $ — $ 19,382 $ — Liabilities: Foreign exchange derivatives not designated as hedging instruments $ — $ 136 $ — As of December 31, 2018: Cash equivalents: U.S. Treasury money market funds $ 14,710 $ — $ — Commercial paper $ — $ 4,411 $ — Corporate securities $ — $ 2,371 $ — Short-term investments: U.S. government securities $ 15,965 $ — $ — Asset backed securities $ 8,588 Corporate securities $ — $ 19,954 $ — Commercial paper $ — $ 42,022 $ — Liabilities: Contingent consideration $ — $ — $ 12,214 Foreign exchange derivatives not designated as hedging instruments $ — $ 26 $ — |
Summary of Changes in Fair Value of Company's Level 3 Financial Instruments | The following table sets forth a summary of the changes in the fair value of the Company’s Level 3 financial instruments (in thousands) for the nine months ended September 30, 2019 and year ended December 31, 2018: Contingent Consideration As of December 31, 2017 $ 11,948 Change in fair value 266 Balance at December 31, 2018 $ 12,214 Change in fair value 219 Settlement of contingent liability (12,433 ) Balance at September 30, 2019 $ — |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Equity [Abstract] | |
Summary of Company's Common Stock | The following is a summary of the Company’s common stock at September 30, 2019 and December 31, 2018. September 30, 2019 December 31, 2018 Common stock authorized 200,000,000 200,000,000 Common stock outstanding 41,208,261 35,146,096 |
Company's Shares of Common Stock Reserved for Issuance | The Company’s shares of common stock reserved for issuance as of September 30, 2019 and December 31, 2018 were as follows: September 30, 2019 December 31, 2018 Warrants acquired in merger 718,373 750,840 Warrants converted pursuant to merger 72,869 72,869 April 2017 SVB Warrants 24,725 24,725 June 2017 SVB Warrants 41,736 41,736 December 2018 SVB Warrants 11,332 11,332 Pre-funded warrants 775,000 775,000 Stock options outstanding 3,247,910 3,077,264 Issued and nonvested RSU's 128,375 156,250 Total shares reserved 5,020,320 4,910,016 |
Summary of Outstanding Warrants for Company's Common Stock | The following table summarizes the outstanding warrants for the Company’s common stock as of September 30, 2019: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 314,446 $ 52.50 November 2019 403,927 $ 29.40 February 2021 72,869 $ 8.98 June 2021 775,000 $ 0.01 October 2024 24,725 $ 9.10 April 2027 41,736 $ 5.39 June 2027 11,332 $ 8.824 December 2028 1,644,035 |
Commitments and Settlement (Tab
Commitments and Settlement (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of Maturity Analysis of Annual Undiscounted Cash Flows Reconciled to Carrying Value of Operating Lease Liabilities | The following is a maturity analysis of the annual undiscounted cash flows reconciled to the carrying value of the operating lease liabilities as of September 30, 2019 (in thousands): Year ending December 31, 2019 $ 200 2020 478 2021 184 2022 67 Total future minimum lease payments $ 929 Less imputed interest (57 ) Total $ 872 |
Schedule of Lease Cost and Other Information | For the three months ended September 30, 2019 For the nine months ended September 30, 2019 Lease cost: Operating lease cost $ 376 $ 1,117 Sublease income (153 ) (461 ) Total lease cost $ 223 $ 656 Other information: Operating cash flows from operating leases $ 198 $ 587 Weighted-average remaining lease term (in months) - operating leases 19.9 19.9 Weighted-average discount rate - operating leases 8.5 % 8.5 % |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock-based Awards for 2008 Plan and 2015 Plan | The following table provides a summary of stock-based awards for the 2008 Plan and 2015 Plan for the nine months ended September 30, 2019 and 2018: Nine months ended September 30, 2019 Nine months ended September 30, 2018 Stock Options RSUs Total Stock Options RSUs Total Outstanding as of December 31 3,077,264 156,250 3,233,514 1,916,832 86,875 2,003,707 Granted 347,125 34,000 381,125 1,016,720 120,000 1,136,720 Exercised (136,729 ) (39,375 ) (176,104 ) (175,407 ) (37,500 ) (212,907 ) Forfeited (39,750 ) (22,500 ) (62,250 ) (123,850 ) — (123,850 ) Outstanding as of September 30 3,247,910 128,375 3,376,285 2,634,295 169,375 2,803,670 |
Stock-based Compensation Expense included in Accompanying Statements of Operations and Comprehensive Loss | Stock-based compensation expense is included in the following line items in the accompanying statements of operations and comprehensive loss for the three and nine months ended September 30, 2019 and 2018 (in thousands): Three Months Ended Nine Months Ended September 30, 2019 September 30, 2018 September 30, 2019 September 30, 2018 Research and development $ 570 $ 813 $ 1,565 $ 1,186 General and administrative 576 1,175 1,727 1,606 Total stock-based compensation $ 1,146 $ 1,988 $ 3,292 $ 2,792 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-dilutive Weighted-Average Equity Instruments Excluded from Calculation of Diluted Net Loss Per Share | The following weighted-average equity instruments were excluded from the calculation of diluted net loss per share because their effect would have been anti-dilutive for the periods presented: Nine Months Ended September 30, 2019 September 30, 2018 Awards under equity incentive plan 3,247,910 2,634,295 Nonvested restricted shares and restricted stock units 128,375 173,422 Warrants to purchase common stock 869,035 890,170 Total 4,245,320 3,697,887 |
Reconciles Basic Earnings Per Share and Diluted Earnings Per Share of Common Stock | The following table reconciles basic earnings per share of common stock for the three and nine months ended September 30, 2019 and 2018: Three Months Ended Nine Months Ended September 30, 2019 September 30, 2018 September 30, 2019 September 30, 2018 Net loss $ (12,403 ) $ (12,560 ) $ (46,454 ) $ (51,002 ) Net loss attributable to common stockholders (12,403 ) (12,560 ) (46,454 ) (51,002 ) Undistributed earnings and net loss attributable to common stockholders, basic and diluted (12,403 ) (12,560 ) (46,454 ) (51,002 ) Weighted average common shares outstanding, basic and diluted 41,727,259 34,483,563 38,749,002 32,423,510 Basic and diluted EPS $ (0.30 ) $ (0.36 ) $ (1.20 ) $ (1.57 ) |
Description of Business and B_2
Description of Business and Basis of Presentation - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2019USD ($)Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of operating segments | Segment | 1 |
Product revenue from inception to date | $ | $ 0 |
Type of Revenue [Extensible List] | us-gaap:ProductMember |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | |||
Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($)Segment | Sep. 30, 2018USD ($) | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||||
Accumulated deficit | $ (176,173,000) | $ (129,719,000) | |||
Cash flow from operations | (35,177,000) | $ (28,782,000) | |||
Cash and cash equivalents | 17,785,000 | 24,301,000 | |||
Short-term investments | $ 88,496,000 | 86,529,000 | |||
Cash and cash equivalents with original maturities | three months or less | ||||
Carrying value of IPR&D | $ 600,000 | ||||
Changes in carrying value of goodwill | 0 | ||||
Impairment of goodwill | 7,420,000 | ||||
Impairment of IPR&D | $ 21,692,000 | ||||
Operating lease, liability | 872,000 | ||||
Present value of remaining lease payments | 929,000 | ||||
Operating lease, right-of -use asset | $ 800,000 | ||||
Discounted using incremental borrowing rate | 8.50% | ||||
Number of operating segments | Segment | 1 | ||||
Date of agreement | Oct. 8, 2018 | ||||
Contingent milestones or co-marketing commitments met or incurred | $ 0 | ||||
Contingent milestones or co-marketing commitments met or remunerated | 0 | ||||
Contingent Milestones Or Co Marketing Commitments Accrued | $ 0 | ||||
Active Pharmaceutical Ingredients [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Agreement description | Under a manufacture and supply agreement with the active pharmaceutical ingredients (“API”) manufacturer, Savara must make certain payments to the API manufacturer upon achievement of the milestones outlined in the table set forth below. Additionally, upon first receipt of marketing approval by Savara from a regulatory authority in a country for a product containing the API for therapeutic use in humans and ending the earlier of (i) ten (10) years thereafter or (ii) the date a biosimilar of such product is first sold in such country, Savara shall pay the API manufacturer a royalty equal to low-single digits of the net sales in that country. | ||||
aPAP [Member] | Japan [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Percentage of other contingent milestone payments associated with specific regulatory and filing activities | 50.00% | ||||
Other contingent milestone payments associated with specific regulatory and filing activities | $ 750,000 | ||||
License agreement development and commercialization cost | 0 | ||||
aPAP [Member] | Japan [Member] | Maximum [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Other contingent milestone payments associated with specific regulatory and filing activities | $ 800,000 | ||||
NTM [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Royalty percent on net sale after publication of the intellectual property | 0.50% | ||||
Royalty percent on net sale prior publication of the intellectual property | 0.25% | ||||
Nebulizer | Maximum [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Royalty percent on net sale | 5.00% | ||||
Nebulizer | Minimum [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Royalty percent on net sale | 3.50% | ||||
ASC 842 | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Operating lease, liability | $ 1,400,000 | ||||
Present value of remaining lease payments | 1,500,000 | ||||
Operating lease, right-of -use asset | $ 1,400,000 | ||||
Discounted using incremental borrowing rate | 8.50% | ||||
Savara ApS [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Research and development tax credits | 22.00% | ||||
Research and development tax credits receivable | $ 1,600,000 | ||||
Savara ApS [Member] | Prepaid Expenses and Other Current Assets [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Research and development tax credits receivable | $ 800,000 | ||||
Savara ApS [Member] | Other Non-Current Assets [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Research and development tax credits receivable | $ 800,000 | ||||
Savara Australia Pty Limited [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Research and development tax credits | 43.50% | ||||
Savara Australia Pty Limited [Member] | Prepaid Expenses and Other Current Assets [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Research and development tax credits receivable | $ 300,000 | ||||
Scenario, Forecast [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Impairment of goodwill | $ 19,400,000 | ||||
Reduction of carrying value of goodwill to fair value | 0 | ||||
Scenario, Forecast [Member] | IPR&D [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Impairment of IPR&D | $ 0 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Manufacturing and Other Contingent Milestone and Co-Development Payments (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |
Total manufacturing and other commitments | $ 11,267 |
Active Pharmaceutical Ingredients [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Achievement of certain milestones related to validation of API and regulatory approval of Molgradex | 2,600 |
Molgradex Nebulizer Manufacturer [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Achievement of various development activities and regulatory approval of nebulizer utilized to administer Molgradex | 7,417 |
Molgradex Japanese Licensee [Member] | Japan [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Co-marketing and regulatory costs | 750 |
NTM [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
First commercial sale in the U.S. of Molgradex in treatment of NTM | $ 500 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Summary of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Prepaid Expense And Other Assets Current [Abstract] | ||
R&D tax credit receivable | $ 1,140 | $ 1,263 |
Prepaid contracted research and development costs | 319 | 561 |
VAT receivable | 265 | 421 |
Prepaid insurance | 74 | 162 |
Deposits and other | 267 | 107 |
Total prepaid expenses and other current assets | $ 2,065 | $ 2,514 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accrued contracted research and development costs | $ 3,210 | $ 2,044 |
Accrued general and administrative costs | 301 | 371 |
Accrued compensation | 1,177 | 643 |
Foreign currency exchange derivative | 136 | 26 |
Deferred revenue | 250 | |
Lease liability | 564 | |
Other | 41 | |
Total accrued expenses and other current liabilities | $ 5,388 | $ 3,375 |
Short-term Investments - Summar
Short-term Investments - Summary of Major Security and Type of Investments (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 88,393 | $ 86,559 |
Gross Unrealized Gains | 103 | |
Gross Unrealized Losses | (30) | |
Fair Value | 88,496 | 86,529 |
U.S. Government Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 28,475 | 15,967 |
Gross Unrealized Gains | 21 | |
Gross Unrealized Losses | (2) | |
Fair Value | 28,496 | 15,965 |
Asset Backed Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 8,791 | 8,595 |
Gross Unrealized Gains | 16 | |
Gross Unrealized Losses | (7) | |
Fair Value | 8,807 | 8,588 |
Corporate Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 31,745 | 19,975 |
Gross Unrealized Gains | 66 | |
Gross Unrealized Losses | (21) | |
Fair Value | 31,811 | 19,954 |
Commercial Paper [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 19,382 | 42,022 |
Fair Value | $ 19,382 | $ 42,022 |
Short-term Investments - Additi
Short-term Investments - Additional Information (Detail) - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Investments Debt And Equity Securities [Abstract] | ||
Realized gains or losses on investments | $ 0 | $ 0 |
Debt Facility - Additional Info
Debt Facility - Additional Information (Detail) | Apr. 28, 2017USD ($)Tranche$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Sep. 30, 2019USD ($)Trancheshares |
Line Of Credit Facility [Line Items] | |||
Prepayment fee percentage | 6.00% | ||
Warrants issued to purchase shares of common stock | shares | 1,644,035 | ||
Amortization of debt discount | $ 400,000 | ||
April 2017 Warrants [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants, expected term | 10 years | ||
April 2017 Warrants [Member] | Volatility [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants, expected rate | 71.42 | ||
April 2017 Warrants [Member] | Risk Free Interest Rate [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants, expected rate | 2.33 | ||
April 2017 Warrants [Member] | Dividend Yield [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants, expected rate | 0 | ||
April 2017 Warrants [Member] | Common Stock [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants issued to purchase shares of common stock | shares | 24,725 | ||
Exercise price of warrants per share | $ / shares | $ 9.10 | ||
Warrants expiration term | 10 years | ||
Warrants expiration date | Apr. 28, 2027 | ||
June 2017 Warrants [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants, expected term | 10 years | ||
June 2017 Warrants [Member] | Volatility [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants, expected rate | 71.57 | ||
June 2017 Warrants [Member] | Risk Free Interest Rate [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants, expected rate | 2.16 | ||
June 2017 Warrants [Member] | Dividend Yield [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants, expected rate | 0 | ||
June 2017 Warrants [Member] | Common Stock [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants issued to purchase shares of common stock | shares | 41,736 | ||
Exercise price of warrants per share | $ / shares | $ 5.39 | ||
Warrants expiration term | 10 years | ||
Warrants expiration date | Jun. 15, 2027 | ||
December 2018 Warrants [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants, expected term | 10 years | ||
Amortization of debt discount | $ 100,000 | ||
December 2018 Warrants [Member] | Volatility [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants, expected rate | 80.09 | ||
December 2018 Warrants [Member] | Risk Free Interest Rate [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants, expected rate | 2.98 | ||
December 2018 Warrants [Member] | Dividend Yield [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants, expected rate | 0 | ||
December 2018 Warrants [Member] | Common Stock [Member] | |||
Line Of Credit Facility [Line Items] | |||
Warrants issued to purchase shares of common stock | shares | 11,332 | ||
Exercise price of warrants per share | $ / shares | $ 8.824 | ||
Warrants expiration term | 10 years | ||
Warrants expiration date | Dec. 4, 2028 | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | |||
Line Of Credit Facility [Line Items] | |||
Number of tranches | Tranche | 2 | 2 | |
Loan and security agreement, maximum amount | $ 15,000,000 | $ 45,000,000 | |
Loan agreement amendment date | Oct. 31, 2017 | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan | |||
Line Of Credit Facility [Line Items] | |||
Interest rate, basis spread | 3.00% | ||
Debt instrument interest only payment maturity date | 2020-10 | ||
Debt instrument principal and interest payment period | 25 months | ||
Debt instrument extended interest only payment maturity date | 2022-11 | ||
Prepayment fee percentage | 6.00% | ||
Payments of debt issuance costs | $ 100,000 | ||
Prepayment description | (i) a prepayment fee (3.0% of funded amounts in months 1-12, 2.0% of funded amounts in months 13-24, and 1.0% thereafter); and (ii) an end of term charge equal to 6.0% of the amount of principal borrowed. | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan | Prepayment Fee 1-12 Months [Member] | |||
Line Of Credit Facility [Line Items] | |||
Prepayment fee percentage | 3.00% | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan | Prepayment Fee 13-24 Months [Member] | |||
Line Of Credit Facility [Line Items] | |||
Prepayment fee percentage | 2.00% | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Term Loan | Prepayment Fee Thereafter [Member] | |||
Line Of Credit Facility [Line Items] | |||
Prepayment fee percentage | 1.00% | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | First Tranche [Member] | |||
Line Of Credit Facility [Line Items] | |||
Loan and security agreement, maximum amount | $ 25,000,000 | ||
Line of credit refinance outstanding amount | $ 15,000,000 | ||
Loan and Security Agreement [Member] | Silicon Valley Bank [Member] | Second Tranche [Member] | |||
Line Of Credit Facility [Line Items] | |||
Loan and security agreement, amount expired | $ 20,000,000 | ||
Line of credit, expiration date | Sep. 30, 2019 |
Debt Facility - Summary of Comp
Debt Facility - Summary of Components of Debt Facility Carrying Value (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Debt Disclosure [Abstract] | ||
Principal payments to lender and end of term charge, Long-term | $ 25,341 | |
Debt issuance costs, Long-term | (202) | |
Debt discount related to warrants, Long-term | (177) | |
Carrying Value, Long-term | $ 24,962 | $ 24,530 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Fair Value of Financial Instruments (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Short-term investments: | ||
Short-term investments | $ 88,496 | $ 86,529 |
U.S. Government Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 28,496 | 15,965 |
Asset Backed Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 8,807 | 8,588 |
Corporate Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 31,811 | 19,954 |
Commercial Paper [Member] | ||
Short-term investments: | ||
Short-term investments | 19,382 | 42,022 |
Fair Value, Measurements, Recurring [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Repurchase Agreements [Member] | ||
Cash equivalents: | ||
Cash equivalents | 8,000 | |
Fair Value, Measurements, Recurring [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Treasury Money Market Funds [Member] | ||
Cash equivalents: | ||
Cash equivalents | 5,109 | 14,710 |
Fair Value, Measurements, Recurring [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. Government Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 28,496 | 15,965 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Liabilities: | ||
Foreign exchange derivatives not designated as hedging instruments | 136 | 26 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Asset Backed Securities [Member] | ||
Short-term investments: | ||
Short-term investments | 8,807 | 8,588 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Corporate Securities [Member] | ||
Cash equivalents: | ||
Cash equivalents | 2,371 | |
Short-term investments: | ||
Short-term investments | 31,811 | 19,954 |
Fair Value, Measurements, Recurring [Member] | Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Cash equivalents: | ||
Cash equivalents | 4,411 | |
Short-term investments: | ||
Short-term investments | $ 19,382 | 42,022 |
Fair Value, Measurements, Recurring [Member] | Significant Unobservable Inputs (Level 3) [Member] | ||
Liabilities: | ||
Contingent consideration | $ 12,214 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Changes in Fair Value of Company's Level 3 Financial Instruments (Detail) - Contingent Consideration [Member] - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Fair Value Liabilities Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | $ 12,214 | $ 11,948 |
Change in fair value | 219 | 266 |
Settlement of contingent liability | $ (12,433) | |
Ending balance | $ 12,214 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | ||
Fair value, assets, level 1 to level 2 transfers, amount | $ 0 | $ 0 |
Fair value, assets, level 2 to level 1 transfers, amount | 0 | 0 |
Fair value, assets, transfers into level 3, amount | 0 | 0 |
Fair value, assets, transfers out of level 3, amount | $ 0 | $ 0 |
Derivative Financial Instrume_2
Derivative Financial Instruments - Additional Information (Detail) $ in Millions | Sep. 30, 2019USD ($) |
Accrued Expenses and Other Current Liabilities [Member] | |
Derivative [Line Items] | |
Derivative financial instruments estimated fair value | $ 0.1 |
Forward Exchange Contracts [Member] | |
Derivative [Line Items] | |
Unsettled forward exchange contracts to purchase foreign currency | 3 |
Derivative liabilities, fair value | $ 3.1 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Jul. 12, 2018 | Sep. 30, 2018 | Sep. 30, 2019 | Dec. 31, 2018 | Apr. 28, 2017 |
Class of Warrant or Right [Line Items] | |||||
Common stock, par value | $ 0.001 | $ 0.001 | |||
Value of shares sold prior to amendment | $ 45,792 | ||||
Common and preferred stock, shares authorized | 201,000,000 | ||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | |||
Preferred stock, shares authorized | 1,000,000 | ||||
Preferred stock, par value | $ 0.001 | ||||
Common Stock [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Value of shares sold prior to amendment | $ 4 | ||||
H.C. Wainwright & Co., LLC [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Common stock, par value | $ 0.001 | ||||
Sales commissions in fixed percentage of gross proceeds per share | 3.00% | ||||
Common stock, shares sold | 4,769,726 | ||||
Net proceeds from sale of shares | $ 29,600 | ||||
H.C. Wainwright & Co., LLC [Member] | Common Stock [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Value of shares sold prior to amendment | $ 2,300 | ||||
H.C. Wainwright & Co., LLC [Member] | Maximum [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Amount available to sell under equity program | $ 60,000 |
Shareholders' Equity - Summary
Shareholders' Equity - Summary of Company's Common Stock (Detail) - shares | Sep. 30, 2019 | Dec. 31, 2018 |
Equity [Abstract] | ||
Common stock authorized | 200,000,000 | 200,000,000 |
Common stock outstanding | 41,208,261 | 35,146,096 |
Shareholders' Equity - Company'
Shareholders' Equity - Company's Shares of Common Stock Reserved for Issuance (Detail) - shares | Sep. 30, 2019 | Dec. 31, 2018 |
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 5,020,320 | 4,910,016 |
Warrants Acquired in Merger [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 718,373 | 750,840 |
Warrants Converted Pursuant to Merger [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 72,869 | 72,869 |
April 2017 SVB Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 24,725 | 24,725 |
June 2017 SVB Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 41,736 | 41,736 |
December 2018 SVB Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 11,332 | 11,332 |
Pre-funded Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 775,000 | 775,000 |
Stock Options Outstanding [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 3,247,910 | 3,077,264 |
Issued and nonvested RSU's [Member] | ||
Class of Warrant or Right [Line Items] | ||
Total shares reserved | 128,375 | 156,250 |
Shareholders' Equity - Summar_2
Shareholders' Equity - Summary of Outstanding Warrants for Company's Common Stock (Detail) | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 1,644,035 |
Exercise Price One [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 314,446 |
Exercise Price | $ / shares | $ 52.50 |
Expiration Date | 2019-11 |
Exercise Price Two [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 403,927 |
Exercise Price | $ / shares | $ 29.40 |
Expiration Date | 2021-02 |
Exercise Price Three [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 72,869 |
Exercise Price | $ / shares | $ 8.98 |
Expiration Date | 2021-06 |
Exercise Price Four [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 775,000 |
Exercise Price | $ / shares | $ 0.01 |
Expiration Date | 2024-10 |
Exercise Price Five [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 24,725 |
Exercise Price | $ / shares | $ 9.10 |
Expiration Date | 2027-04 |
Exercise Price Six [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 41,736 |
Exercise Price | $ / shares | $ 5.39 |
Expiration Date | 2027-06 |
Exercise Price Seven [Member] | |
Class of Warrant or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 11,332 |
Exercise Price | $ / shares | $ 8.824 |
Expiration Date | 2028-12 |
Commitments and Settlement - Ad
Commitments and Settlement - Additional Information (Detail) $ in Thousands | Nov. 29, 2017USD ($) | Mar. 23, 2017ft² | Sep. 30, 2019USD ($) | Nov. 30, 2019USD ($) |
Commitments And Contingencies [Line Items] | ||||
Lease commencement date | Jan. 1, 2018 | Jul. 1, 2017 | Nov. 1, 2018 | |
Lease expiration date | Jul. 31, 2021 | May 31, 2020 | Sep. 30, 2022 | |
Annual rental payments | $ 200 | $ 100 | ||
Percentage of lease increase | 2.00% | |||
Lease office space | ft² | 13,707 | |||
Lease agreement date | Jun. 19, 2014 | |||
Annual sublease rental payments | $ 500 | |||
Operating lease, right-of -use asset | $ 800 | |||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsNoncurrent | |||
Operating lease, liability | $ 872 | |||
Operating lease, liability, current portion | $ 600 | |||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:AccruedLiabilitiesCurrent | |||
Operating lease, liability, non-current portion | $ 300 | |||
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | us-gaap:LiabilitiesOtherThanLongtermDebtNoncurrent | |||
Employment agreement description | Upon termination without cause, and not as a result of death or disability or resignation for good reason, each of such officers is entitled to receive a payment of base salary for twelve months and a pro-rated portion of their unpaid bonus following termination of employment, and such officer will be entitled to continue to receive coverage under medical and dental benefit plans for twelve months or until such officer is covered under a separate plan from another employer. Upon a termination other than for cause or resignation for good reason within twelve months following a change in control, each of such officers is entitled to receive a payment of base salary for eighteen months and one-hundred percent of their unpaid bonus following termination of employment and such officer will be entitled to continue to receive coverage under medical and dental benefit plans for twelve months or until such officer is covered under a separate plan from another employer and will also be entitled to certain acceleration of such officer’s outstanding nonvested options at the time of such termination. | |||
Percentage of unpaid bonus to be paid upon termination other than for cause or for good reason | 100.00% | |||
Scenario, Forecast [Member] | ||||
Commitments And Contingencies [Line Items] | ||||
Annual rental payments | $ 100 |
Commitments and Settlement - Sc
Commitments and Settlement - Schedule of Maturity Analysis of Annual Undiscounted Cash Flows Reconciled to Carrying Value of Operating Lease Liabilities (Detail) $ in Thousands | Sep. 30, 2019USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2019 | $ 200 |
2020 | 478 |
2021 | 184 |
2022 | 67 |
Total future minimum lease payments | 929 |
Less imputed interest | (57) |
Operating lease, liability | $ 872 |
Commitments and Settlement - _2
Commitments and Settlement - Schedule of Lease Cost and Other Information (Detail) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2019USD ($) | Sep. 30, 2019USD ($) | |
Lease cost: | ||
Operating lease cost | $ 376 | $ 1,117 |
Sublease income | (153) | (461) |
Total lease cost | 223 | 656 |
Other information: | ||
Operating cash flows from operating leases | $ 198 | $ 587 |
Weighted-average remaining lease term (in months) - operating leases | 23 months 24 days | 23 months 24 days |
Discounted using incremental borrowing rate | 8.50% | 8.50% |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2019shares | |
2008 Stock Option Plan [Member] | Stock Options [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting interval period | quarterly |
Vesting expiration period | 10 years |
Issuance of stock based awards | 0 |
2008 Stock Option Plan [Member] | Restricted Stock [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting interval period | quarterly |
Vesting period | 4 years |
Vesting expiration period | 10 years |
2008 Stock Option Plan [Member] | Tranche One [Member] | Stock Options [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting period | 3 years |
2008 Stock Option Plan [Member] | Tranche Two [Member] | Stock Options [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting period | 4 years |
2015 Omnibus Incentive Option Plan [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Common stock available for grant | 1,265,733 |
2015 Omnibus Incentive Option Plan [Member] | Stock Options [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting period | 4 years |
Vesting expiration period | 10 years |
Dividend yield | 0.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-based Awards for 2008 Plan and 2015 Plan (Detail) - 2008 Plan and 2015 Plan [Member] - shares | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock Options, Outstanding at beginning balance | 3,077,264 | 1,916,832 |
Stock Options, Granted | 347,125 | 1,016,720 |
Stock Options, Exercised | (136,729) | (175,407) |
Stock Options, Forfeited | (39,750) | (123,850) |
Stock Options, Outstanding at ending balance | 3,247,910 | 2,634,295 |
RSUs, Outstanding at beginning balance | 156,250 | 86,875 |
RSUs, Granted | 34,000 | 120,000 |
RSUs, Exercised | (39,375) | (37,500) |
RSUs, Forfeited | (22,500) | |
RSUs, Outstanding at ending balance | 128,375 | 169,375 |
Total, Outstanding at beginning balance | 3,233,514 | 2,003,707 |
Total, Granted | 381,125 | 1,136,720 |
Total, Exercised | (176,104) | (212,907) |
Total, Forfeited | (62,250) | (123,850) |
Total, Outstanding at ending balance | 3,376,285 | 2,803,670 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-based Compensation Expense included in Accompanying Statements of Operations and Comprehensive Loss (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 1,146 | $ 1,988 | $ 3,292 | $ 2,792 |
Research and Development [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | 570 | 813 | 1,565 | 1,186 |
General and Administrative [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 576 | $ 1,175 | $ 1,727 | $ 1,606 |
License Agreement - Additional
License Agreement - Additional Information (Detail) $ in Millions | 1 Months Ended |
Oct. 31, 2018USD ($) | |
aPAP [Member] | Japan [Member] | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |
Receipt of milestone payment | $ 0.3 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Anti-dilutive Weighted-Average Equity Instruments Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 4,245,320 | 3,697,887 |
Awards under Equity Incentive Plan [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 3,247,910 | 2,634,295 |
Nonvested Restricted Shares and Restricted Stock Units [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 128,375 | 173,422 |
Warrants to Purchase Common Stock [Member] | ||
Earnings Per Share Basic [Line Items] | ||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 869,035 | 890,170 |
Net Loss Per Share - Reconciles
Net Loss Per Share - Reconciles Basic Earnings Per Share and Diluted Earnings Per Share of Common Stock (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Earnings Per Share [Abstract] | ||||||||
Net loss | $ (12,403) | $ (21,939) | $ (12,112) | $ (12,560) | $ (11,594) | $ (26,848) | $ (46,454) | $ (51,002) |
Net loss attributable to common stockholders | (12,403) | (12,560) | (46,454) | (51,002) | ||||
Undistributed earnings and net loss attributable to common stockholders, basic and diluted | $ (12,403) | $ (12,560) | $ (46,454) | $ (51,002) | ||||
Weighted average common shares outstanding, basic and diluted | 41,727,259 | 34,483,563 | 38,749,002 | 32,423,510 | ||||
Basic and diluted EPS | $ (0.30) | $ (0.36) | $ (1.20) | $ (1.57) |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |
Dec. 31, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | |
Subsequent Event [Line Items] | |||
Impairment of goodwill | $ 7,420,000 | ||
Impairment of IPR&D | $ 21,692,000 | ||
Scenario, Forecast [Member] | |||
Subsequent Event [Line Items] | |||
Impairment of goodwill | $ 19,400,000 | ||
Reduction of carrying value of goodwill to fair value | 0 | ||
Scenario, Forecast [Member] | IPR&D [Member] | |||
Subsequent Event [Line Items] | |||
Impairment of IPR&D | $ 0 |